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Notificaciones De Seguridad De Campo acerca de AidFast, 1st Aid & Powerplast Digital Thermometers
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2009(03)
  • Fecha
    2009-04-23
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/aidfast-1st-aid-powerplast-digital-thermometers&id=2d93f825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    Non-compliant and inaccurate (up to 0.5°c) aid fast, 1st aid and powerplast digital thermometers have been provided to discount outlets in ireland.  these digital thermometers are not appropriately ce marked.  these thermometers may be marketed under a variety of brands and the packaging may vary.
  • Acción
    Advice for Pharmacies, Retailers and Wholesalers  Pharmacies, retailers and wholesalers should examine their stock to determine if they have any medical devices branded Aid Fast, 1st Aid or Powerplast digital thermometers.   If you find that you have these products cease sale of these products immediately and quarantine all stock.  Contact the IMB immediately to obtain further instruction and guidance.   Also, should you discover any other similar brands of digital thermometers that do not clearly identify the manufacturers name and address on the packaging, please advise the IMB.   Advice for Consumers Consumers should check their digital thermometer to determine if their device is branded Aid Fast, 1st Aid or Powerplast.   If you find that you have one of these devices, discontinue use immediately and seek an alternative.  Consumers with health concerns should consult with their general practitioner.
Notificaciones De Seguridad De Campo acerca de ‘First Steps’ Medicine Feeder
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2009(05)
  • Fecha
    2009-06-18
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/first-steps-medicine-feeder&id=4c99f825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    Non-compliant ‘first steps’ medicine feeders have been provided to retail outlets in ireland by rsw international limited. these medicine feeders are not appropriately ce marked.
  • Acción
    Advice for Pharmacies, Retailers and Wholesalers Pharmacies, retailers and wholesalers should examine their stock to determine if they have any medical devices from the ‘First Steps’ medicine feeder range.  If you find that you have these products, cease sale of these products immediately and quarantine all stock. Contact the IMB immediately to obtain further instruction and guidance.  Also, should you discover any other similar brands of medicine feeders that do not carry the CE mark, please advise the IMB. Advice for Consumers  Consumers should check their medicine feeders to determine if their device is branded ‘First Steps’ medicine feeder range.  If you find that you have one of these devices, discontinue use immediately and seek an alternative. Consumers with health concerns should consult with their general practitioner.
Notificaciones De Seguridad De Campo acerca de Contoura 880 Beds
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2009-08-21
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/contoura-880-beds&id=de8cf825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    Some bed rail support brackets have been found to have poor welds causing them to fail in use. patients are at risk of injury from a fall if the bed rails fail in use.
  • Acción
    1) Ensure the appropriate personnel are made aware of this notice.  2) Identify the location of all Contoura 880 beds.  3) Determine if your institution has devices affected by this issue.  This can be determined by:       A) Checking the manufacturing date to see if it is between December 1999 and June 2001.       B) Checking if the Serial number lies in the range 167386 to 382938.  4) Check the support bracket on the frame and if cracking is found contact the manufacturer who will provide and fit replacement brackets free of charge.  5) Ensure that correction is completed on all affected devices.
Notificaciones De Seguridad De Campo acerca de Optium Xceed meters manufactured by Abbott Diabete...
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2009(08)
  • Fecha
    2009-10-23
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/blood-glucose-meters-and-test-strips-23.10.2009&id=f992f825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    The optium xceed blood glucose meter (manufactured by abbott diabetes care) or boots brand blood glucose meters, may generate incorrect results when used in conjunction with the onetouch ultra test strips, manufactured by lifescan.
  • Acción
    The IMB recommends that users follow the manufacturer’s instructions for use and User’s Guide to determine which blood glucose meters and test strips are compatible.  Table showing compatible meters and test strips  Manufacturer Meter Compatible test strip Abbott Diabetes Care Optium Xceed Optium Plus test strips (foil wrapped) Boots Boots Brand Optium Plus test strips (foil wrapped) LifeScan OneTouch Ultra OneTouch Ultra 2 OneTouch UltraEasy OneTouch UltraSmart OneTouch Ultra test strips Pharmacists supplying OneTouch Ultra test strips and Optium Xceed or Boots brand meters:  If you supply Optium Xceed or Boots brand meters you should advise the user to only use Optium Plus test strips. When you dispense OneTouch Ultra test strips you should advise the user that these test strips are only intended for use with the OneTouch Ultra brand meters.   GPs prescribing blood glucose meter test strips: Only prescribe Optium Plus test strips for use with Optium Xceed or Boots brand meters.  Only prescribe OneTouch Ultra test strips for use with OneTouch Ultra brand meters.  Healthcare professionals managing patients who use the affected devices:   Advise patients to ensure that they are using the correct test strips for their meter as described in the meter’s user manual.     Healthcare professionals who use these devices:  Ensure that Optium Plus test strips are only used with the Optium Xceed or Boots brand meters. Ensure that OneTouch Ultra test strips are only used with the OneTouch Ultra brand meters. General public:  Only use Optium Plus test strips with the Optium Xceed or Boots brand meters. Only use OneTouch Ultra test strips with OneTouch Ultra brand meters. Please bring this safety notice to the attention of all who need to be aware of it. This will include further distribution to:  Accident & Emergency Departments  All wards  Ambulance services directors  Ambulance staff  Biochemists  Chief pharmacists  Clinical pathologists  Clinical pathology directors  Day surgery units  Diabetes clinics / outpatients  Diabetes nurse specialists  Hospital pharmacists  Medical Directors  Nursing executive directors  Outpatient clinics  Outpatient theatre managers  Outpatients theatre nurses  Pharmacists  Point of care testing co-ordinators  Risk managers  The IMB has also published an Information leaflet on safety tips for blood glucose meters. Please see the Information leaflets section on the Publications page of the website.
Notificaciones De Seguridad De Campo acerca de Trauma External Fixation System (Small, Medium, Di...
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2014(36)
  • Fecha
    2014-08-12
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/SN201436&id=74190126-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Zoll AED Plus Defibrillator
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2009-12-10
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/zoll-aed-plus-defibrillator-10.12.2009&id=2a8cf825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    The zoll aed plus defibrillator may not deliver therapy.
  • Acción
    1. Ensure that the relevant personnel in your organisation are made aware of this issue.  2. Determine if you have purchased the affected serial numbers of this product, AED Plus devices with serial numbers below X_ _ _200000.  3. If you have an affected device confirm that the recommended actions have been completed:  Ensure that the date when the batteries were installed in your device has been checked.  a. If batteries were installed more than three (3) years ago, replace the batteries as soon as possible and add the label provided by Zoll showing the next scheduled replacement date. Read and add the addendum incorporating this information to the administrator’s guide that was provided by Zoll.  b. If batteries are not more than three (3) years old, add the label provided by Zoll completed with the next scheduled replacement date. Read and add the addendum, provided by Zoll, incorporating this information to the administrator’s guide.
Notificaciones De Seguridad De Campo acerca de Oxy-Top 5 / Oxy-Tec 5 Oxygen Concentrator
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2009(12)
  • Fecha
    2009-12-10
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/oxy-top-5-oxy-tec-5-oxygen-concentrator&id=548cf825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    Risk of ignition of oxy-top 5 / oxy-tec 5 oxygen concentrators.
  • Acción
    Advice for Retailers and Wholesalers  (1) Retailers and wholesalers should examine their stock to determine if they have any medical devices branded Oxy-Top 5 / Oxy-Tec 5 oxygen concentrators.  (2) If you have these devices, cease sale of these devices immediately and quarantine all stock. Contact the IMB immediately to obtain further instruction and guidance.  (3) Ensure the appropriate personnel are made aware of this notice.  Advice for Healthcare Institutions / Consumers  (1) Check your oxygen concentrator to determine if it is branded Oxy-Top 5 / Oxy- Tec 5.  (2) Examine the information for use provided with the device to determine if either the name or manufacturer details match those provided above.  (3) If you find that you have one of these devices, discontinue use immediately and seek an alternative. Please quarantine the device and contact the IMB to obtain further instruction and guidance.  (4) Ensure the appropriate personnel are made aware of this notice.
Notificaciones De Seguridad De Campo acerca de Wallach LL100 Cryosurgical System CO2 and Accessories
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2010(01)
  • Fecha
    2010-02-18
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/wallach-ll100-cryosurgical-system-co2-and-accessories&id=fe8bf825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    A manufacturing problem has been detected where under certain circumstances a restriction of the flow of carbon dioxide gas within the handle may result in a less than optimum temperature delivery to the treatment site.
  • Acción
    1) Ensure the appropriate personnel are made aware of this notice.  2) Identify the location of all Wallach LL100 Cryosurgical System CO2 and Accessories.  3) Follow the instructions outlined in the attached FSN from Wallach Surgical regarding this action.
Notificaciones De Seguridad De Campo acerca de ARCHITECT Anti-HCV Reagents
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2010(02)
  • Fecha
    2010-04-15
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/architect-anti-hcv-reagents&id=d98bf825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    Abbott has determined that s/co values generated with architect anti-hcv (ln 6c37) may decrease when 25% or less of test volume is remaining leading to:  • abbott positive control values shift down and/or out of range low, • non-abbott positive control values shift down and/or out of range low, and/or • a decrease in patient result values.
  • Acción
    Abbott has issued a Field Safety Notice (FSN) (March 2010) to all Irish customers using the ARCHITECT Anti-HCV assay recommending customers mix the ARCHITECT Anti-HCV assay diluent (LN 6C37J, green bottle label) prior to testing each day of use.
Notificaciones De Seguridad De Campo acerca de M Series Heated Humidifier
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2010(04)
  • Fecha
    2010-05-17
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/m-series-heated-humidifier&id=848bf825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    Certain philips respironics humidifiers may present a risk of potential burn if handled while exhibiting thermal deformation due to a connector failure. this is due to an intermittent connection between the heater plate and the printed circuit board which results in a blinking led on the humidifier control knob.
  • Acción
    1) Ensure the appropriate personnel are made aware of this notice.  2) Identify the location of all Philips Respironics M Series Heated Humidifiers.  3) Determine if your institution has devices affected by this issue (check the serial numbers).  4) Examine the humidifier control knob for a blinking blue light as shown in the attached field safety notice issued by the manufacturer.  5) Ensure that corrective action is completed on all affected devices.
Notificaciones De Seguridad De Campo acerca de Intracranial Stent SILK
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2010(06)
  • Fecha
    2010-06-14
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/intracranial-stent-silk&id=3a8bf825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    Potential for patient death if the device is used to treat intracranial aneurysms without using embolisation coils.
  • Acción
    • Ensure the appropriate personnel are made aware of this notice.  • Ensure that the patient follow up recommended by the manufacturer is followed (please see above).
Notificaciones De Seguridad De Campo acerca de PROXIMATE® PPH PROCEDURE FOR PROLAPSE AND HEMORRHO...
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2010(07)
  • Fecha
    2010-07-16
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/counterfeit-proximate-pph-procedure-for-prolapse-and-hemorrhoids-set&id=ce92f825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    The potential supply and use of a counterfeit haemorrhoidal circular stapler product called proximate® pph procedure for prolapse and hemorrhoids set, product code pph03, from the above batch that is not guaranteed to meet the required standards of safety and quality, as required by the medical devices legislation.
  • Acción
    The IMB advises that:  All product in your possession should be checked using the details above to assess whether the product is genuine or counterfeit.  • If from your assessment you determine or suspect that you have product that is counterfeit, quarantine the product to ensure it will not be used and contact your local EES representative, JOhnson Ireland, who will be able to confirm if the product is authentic.  • If you identify that you have product that is counterfeit you should return any such affected product in your possession to  Johnson & Johnson Ireland, and inform the IMB.
Notificaciones De Seguridad De Campo acerca de LIFEPAK® CR Plus Automatic External Defibrillator
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2010(08)
  • Fecha
    2010-07-19
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/lifepak-cr-plus-automatic-external-defibrillator&id=0b8bf825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    The potential for the lifepak® cr plus to not deliver therapy still exists due to a device upgrade that has not been completed on all of the affected devices on the irish market.
  • Acción
    1. Ensure the appropriate personnel are made aware of this notice.  2. Identify affected LIFEPAK® CR Plus defibrillators (Please see Attachment 1 for affected serial numbers)  3. Confirm if defibrillators have been upgraded by Oxygen Care (repair and servicing company for Physio-Control products in Ireland) in relation to this issue.  4. If any of the affected defibrillators has not been upgraded, immediately contact Medtronic or Oxygen Care (see contact details below) to arrange the correction of the defibrillator, and follow the recommendations listed in the FSN.  5. Perform regular monthly inspection as per LIFEPAK® CR Plus operating instructions AND verify that the voice prompt is heard at power on.  6. If, at any time, the voice prompt is not heard or any other indicator displays bar “OK”, immediately contact Medtronic.
Notificaciones De Seguridad De Campo acerca de ASR™ Articular Surface Replacement and ASR™ XL Ace...
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2010(10
  • Fecha
    2010-08-27
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/asr-articular-surface-replacement-and-asr-xl-acetabular-system&id=b78af825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    Recall of depuy’s asr™ hip implant system due to higher than expected revision rate.
Notificaciones De Seguridad De Campo acerca de Stryker Model 6100 M1 Ambulance Cot
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2010(012)
  • Fecha
    2010-09-30
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/stryker-model-6100-m1-ambulance-cot&id=6d8af825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    Stryker has become aware that the head end slide tube, bushings and head end release rod of the model 6100 m1 ambulance cot can break during use, potentially resulting in the head end of the cot collapsing.
  • Acción
    As there are no sales records, the IMB are requesting that healthcare workers contact Stryker UK if they are aware that this device has been distributed in Ireland.  If affected devices are located at your facility and the unit does not operate properly, remove the unit from service and contact Stryker UK to arrange for a device retrofit / upgrade. The attached field safety notice issued by Stryker provides further information on this issue.
Notificaciones De Seguridad De Campo acerca de Silicone Gel filled Breast Implants manufactured b...
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2010(13)
  • Fecha
    2010-10-05
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/silicone-gel-filled-breast-implants-manufactured-by-poly-implant-prothese-(pip).-(all-models-and-lot-numbers)-05-10.2010&id=388af825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    A recall of silicone gel filled breast implants manufactured by the french company poly implant prothese (pip) was initiated in ireland on the 30th march 2010. the recall follows a manufacturing site inspection in france which identified unauthorised silicone gel being used in the product.
  • Acción
    The IMB recommends that:  Implanting surgeons / Implanting centres  • Identify women who were implanted with PIP silicone gel filled implants after 01 January 2001.  • Reassure them that there is no current evidence of health risk associated with the implants.  • Advise them that further information about the testing is available on the IMB, Therapeutic Goods Administration in Australia, Medicines And Healthcare products Regulatory Agency in UK and French Regulatory Agency AFSSAPs websites. (web addresses provided above).  GPs  Advise patients who are concerned about their PIP implants to consult their implanting surgeon/ implanting centres.
Notificaciones De Seguridad De Campo acerca de Nellcor Durasensor® (DS-100A) sensors\Product Code...
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2010(17)
  • Fecha
    2010-12-22
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/counterfeit-covidien-nellcor-spo2-durasensor-(ds-100a)-sensors-22.12.2010&id=9f89f825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    The potential supply and use of counterfeit nellcor spo2 durasensor (ds-100a) sensors that are not guaranteed to meet the required standards of safety and quality, as required by the medical devices legislation.
  • Acción
    The IMB  advises that:  • All products in your possession should be checked using the details above to assess whether the product is genuine or counterfeit.  • If from your assessment you determine or suspect that you have product that is counterfeit, quarantine the product to ensure it will not be used and contact your local Covidien representative, who will be able to confirm if the product is authentic.  • If you identify that you have product that is counterfeit you should return any such affected product in your possession to the local Covidien representative and inform the IMB.  Further Information: All adverse incidents relating to a medical device should be reported to the:  Irish Medicines Board  Kevin O’Malley House  Earlsfort Centre  Earlsfort Terrace  Dublin 2  Telephone: +353-1-6764971  Fax: +353-1-6344033  E-mail: vigilance@HPRA .ie  Website: www.HPRA .ie  Enquiries should be addressed to:  Local Covidien Office:  Deirdre O’Connor at: 087 8168519  Mark Gray at: 087 6538087  Covidien Ireland  Block G, 1st Floor  Loughlinstown  Dublin  Please click here to download a pdf version of the safety Notice « View List Latest Information Provide Feedback   Page Attachments  - Advisory - Counterfeit Covidien Nellcor SpO2 RSS Feeds HPRA Notices RSS Feed
Notificaciones De Seguridad De Campo acerca de Nellcor Durasensor® (DS-100A) sensors Product Code...
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2011(01)
  • Fecha
    2011-01-21
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/counterfeit-covidien-nellcor-spo2-durasensor-(ds-100a)-sensors&id=1589f825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    The supply and use of counterfeit nellcor spo2 durasensor (ds-100a) sensors that are not guaranteed to meet the required standards of safety and quality, as required by the medical devices legislation.
  • Acción
    The IMB advises that:  • All products in your possession should be checked using the details above to assess whether the product is genuine or counterfeit.  • If from your assessment you determine or suspect that you have product that is counterfeit identify, locate and quarantine all product to ensure it will not be used.  • If you identify that you have product that is counterfeit you should submit the information detailed in Appendix I to theHPRA (enforcement@hpra.ie). On receipt of this information the IMB will contact you to advise what further course of action is required.
Notificaciones De Seguridad De Campo acerca de Tosoh Automated Glycohemoglobin Analyzers: HLC-723...
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2014(37)
  • Fecha
    2014-09-08
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/SN2014-37&id=2e3a0126-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
Notificaciones De Seguridad De Campo acerca de Liftmaster 160 (AA8974), Liftmaster 190 (AA8943)
  • Tipo de evento
    Field Safety Notice
  • Fecha
    2011-03-11
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/hpra-safety-notice-liftmaster-160-(aa8974)-liftmaster-190-(aa8943)&id=9588f825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    Old style booms or spreader bars could fail and cause injury to the person being transferred.
  • Acción
    Please review the attached FSN and complete the inspection as requested. Please discontinue the use of any hoists with the old style attachment where the boom locates onto two vertical pins on the motor/gearbox assembly (see FSN for additional information). Users should contact Murray’s Medical Equipment Ltd. to arrange for the supply of a replacement assembly, if required.
Notificaciones De Seguridad De Campo acerca de BHM Medical Inc. Hoists
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2011(04)
  • Fecha
    2011-04-01
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/bhm-medical-inc.-hoists&id=5288f825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    Bhm medical inc. has become aware that a number of hoists may have been fitted with an incorrect power cable on the control box.
  • Acción
    The manufacturer and the distributors of this device in Ireland have been unsuccessful in their attempts to locate all hoists affected by this field safety corrective action (FSCA).  The IMB advises that users:  • Follow the manufacturer’s recommendations as outlined in the attached field safety notice.  • Identify the affected hoists in your facility and contact the manufacturer to arrange for a power cable replacement.  • Remove any affected devices from service pending installation of the new power cable.
Notificaciones De Seguridad De Campo acerca de Level 1® Normothermic IV fluid administration sets...
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2011(05)
  • Fecha
    2011-04-08
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/level-1-normothermic-iv-fluid-administration-sets-for-use-with-the-level-1-fast-flow-fluid-warmer-units&id=f797f825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    Smiths medical has become aware of an increased trend in reports of kinking of the tubing on certain level 1® normothermic iv fluid administration sets (models di-65hl, di-75 and di-150). in some cases, the kink may lead to a decrease in the flow of fluid to the patient. a reduction in flow rate may lead to a delay of therapy, which could result in patient injury.
  • Acción
    The Irish Medicines Board advises users of this product to inspect their inventory and segregate the affected products for return to the manufacturer as per the attached field safety notice.  Users should exercise extreme caution when using the alternative replacement products and remain cognisant of the clinical risks associated with these sets, which are not equipped with the F-50 Gas Vent Filter Assembly.  Users should also take care to:  • Ensure that all Level 1® fast flow fluid warmer units contain a copy of the quick reference guide distributed by Smiths Medical in 2007.  • Contact the manufacturer to request a copy of the quick reference guide if required.
Notificaciones De Seguridad De Campo acerca de Ondal Acrobat 2000 (AC2000)
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2011(07)
  • Fecha
    2011-05-12
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/ondal-acrobat-2000-(ac2000)&id=3587f825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    The acrobat 2000 spring-loaded arms could break. the acrobat 2000 spring arm has been used by a number of different manufacturers to support operating lights and monitors which have been placed on the market in ireland.
  • Acción
    The IMB advises that users:  • Identify the affected spring arms in your facility and contact the appropriate manufacturer for further guidance.  • Follow the manufacturer’s recommendations as outlined in the associated field safety notices.  • Users are advised to exercise caution when moving or repositioning devices connected to these spring arms pending upgrade / inspection by the  manufacturer.
Notificaciones De Seguridad De Campo acerca de Non-sterile Boston Scientific Endoscopy and Urolog...
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2011(08)
  • Fecha
    2011-05-13
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/non-sterile-boston-scientific-endoscopy-and-urology-women-s-health-devices-stolen&id=0c87f825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    Stolen non-sterile boston scientific endoscopy and urology/women’s health products are labelled as “sterile”.
  • Acción
    The IMB advises that you:  • Check your inventory for the affected product  • Monitor all incoming shipments for the affected product  • If you have any of these identified devices in your current inventory or receive any future delivery of these batches of devices, do not use the devices and contact Boston Scientific  • If healthcare professionals suspect or know that the stolen non-sterile devices have been used, it is recommended that they monitor and treat patients accordingly.
Notificaciones De Seguridad De Campo acerca de Zoll AED Plus Defibrillator
  • Tipo de evento
    Field Safety Notice
  • Número del evento
    SN2009(13) Updated Version
  • Fecha
    2011-05-23
  • País del evento
    Ireland
  • Fuente del evento
    HPRA
  • URL de la fuente del evento
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/zoll-aed-plus-defibrillator&id=6e86f825-9782-6eee-9b55-ff00008c97d0
  • Notas / Alertas
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Ireland."
  • Notas adicionales en la data
  • Causa
    The zoll aed plus defibrillator may not deliver therapy.
  • Acción
    1. Ensure that the relevant personnel in your organisation are made aware of this  issue.  2. Determine if you have purchased the affected serial numbers of this product,  AED Plus devices with serial numbers below X_ _ _200000.  3. If you have an affected device confirm that the recommended actions have been completed:  Ensure that the date when the batteries were installed in your device has been checked.  a. If batteries were installed more than three (3) years ago, replace the batteries  as soon as possible and add the label provided by Zoll showing the next  scheduled replacement date. Read and add the addendum incorporating this  information to the administrator’s guide that was provided by Zoll.  b. If batteries are not more than three (3) years old, add the label provided by  Zoll completed with the next scheduled replacement date. Read and add the  addendum, provided by Zoll, incorporating this information to the  administrator’s guide.
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