Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Ambu australia has received reports regarding the potential for the ‘cushion seal to separate from the mask’. to date, there have been no adverse health consequences or medical interventions reported due to this issue.
Acción
AMBU is advising customers to inspect stock and quarantine all AMBU UltraSeal II Anaesthetic Masks. AMBU will arrange collection of all the affected masks
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
B. braun has been identified that some of the items in specific batches have damaged packaging which may affect the sterility of the products. no specific monitoring of patients is recommended at this time.To date, there have been no reports of any adverse patient outcome which could be associated with this potential sterility issue.
Acción
B. Braun is requesting customers:
1. Identify, quarantine and return affected devices;
2. Do not use affected devices anymore;
3. Patients with affected devices in use should be monitored carefully;
4. Inform the responsible personnel in the relevant facilities; and
5. Confirm receipt of the correspondence as per the instructions given in the Customer Letter.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Philips have identified that the first time an operator selects a new procedure type during a single examination, the shutter position resets to the open position for the new procedure type. if the shutters had previously been changed during the examination, that setting is not retained after the first time the procedure type is changed during a single examination.
Acción
Philips is advising this issue will be resolved in a software update, expected to be available in the second half of 2018. Philips will notify users when this software update is available.
Until a software revision that corrects this issue becomes available, users should verify that the desired shutter position is set when performing the run after the first time the procedure type is changed during a single examination. This can be accomplished by first selecting a different procedure and then reselect the original procedure on the Xper Module or on the Data Monitor.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Fujiflm has become aware of a malfunction in the system where inconsistent mitral valve mean pressure gradient values are being reported. the values are only affected when measuring multiple velocity traces in patients with an irregular heart rhythm, with mitral and tricuspid valve stenosis, using the synapse cv measurement tools. multiple traces measured on the modality and transmitted to synapse cv are not affected.To date, there have been no reported patient injuries as a result of this issue. this malfunction does not impact the advances reporting system and there have been no reports of any other measurements or calculations being affected.
Acción
Fujifilm is advising users not to perform sequential multiple velocity trace measurements for mitral, tricuspid, aortic or pulmonic valves in the Synapse Cardiovascular analysis package.
If averaging needs to be performed in Synapse Cardiovascular analysis package, users are advised to follow the steps outlined in the Customer Letter.
This issue has been corrected in Synapse CV 6.1.0 and higher versions
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The zippie zone instructions for use (ifu) have been updated to provide clarification on the intended use and the correct prescription of the wheelchair prior to purchase.
Acción
The IFU updates cover the correct usage of the chair and also improved guidance in the correct product selection and client suitability information.
Customers with this particular chair model may download the updated instructions at:
http://www.sunrisedice.com/asset-bank/assetfile/25518.pdf
If users have any concerns regarding the correct usage/application or prescription regarding the chair they have been supplied, it is advised to discuss these concerns with the therapist or supplier in the first instance.
Sunrise Medical is also providing a new "Paediatric Prescription Guide" to clients, therapists and clinicians as a reference whilst prescribing and/or assessing clients.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Stryker australia has discovered that two (2) lots of tritanium-pl cages, part number 48950066 (lot # a8am) and part number 48954066 (lot # a8t2), were shipped and sold to australia without market release approval. the tritanium-pl cage product family has been registered and approved in australia. however, the specific part numbers 48950066 and 48954066 were not registered in australia.
Acción
Stryker Australia is requesting recipients of the letter to confirm whether they possess any affected stock and to inform any parties who may have received affected stock and to inform Stryker of this using the supplied response forms.
A hazard alert is also being issued.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Philips has received reports of instances where after a continuous operation of more than one and a half days, the image on the flexvision large screen monitor froze for about 15 seconds. thereafter, the system restored itself and was fully operational again.This is only applicable to allura systems with a flexvision large screen monitor. all other monitors to the system are not affected.To date, philips is not aware of any injuries that may have occurred due to this issue.
Acción
Philips is advising this issue will be resolved in a software upgrade, expected to be available by the second half 2018. Users will be contacted by Philips when the software is available for installation.
In the interim, users are advised to restart the system at least once per day to prevent occurrence of this issue.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Becton dickinson (bd) has received reports of leakage which could result in the potential exposure of hazardous drugs to the healthcare worker during preparation, transport or administration.This defect was noted by customers during product use. leakage was observed between the connector to the secondary set spike and the tubing to the spike joint. the defect cannot be detected by visual inspection only. 8 reports relating to this issue have been received in australia. to date, no reports of injury have been received in australia.
Acción
BD is advising customers to immediately review inventory and quarantine affected product. BD will arrange collection of affected stock from facilities.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Siemens have identified that in the event of a short-circuit within the x-ray tube, a current leakage may cause an overload of the x-ray generator. if this current leak remains undetected it may cause damage to the generator by overheating after-which, taking an x-ray will not be possible.
Acción
Siemens are advising they will contact customers to schedule the installation of a Residual Current Device (RCD) on affected generators in order to detect current leakages.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Cook medical has identified the diagram on the product label of the chorion villus biopsy needle set (k-cvns-1821-robinson-et) is incorrect. it shows that the 18ga needle has an echotip, and the 21ga needle does not, whereas the product is designed such that the 21ga needle has the echotip and the 18ga needle does not.The tip of the larger gauge guide needle is likely to be visible on the ultrasound regardless of a non-echogenic tip. in the event that the labelling error resulted in a clinician expecting the echogenic tip to be present on the guide needle, instead of the sampling needle, the clinician may not be able to adequately identify the tip of the inserted access needle.To date, there have been no reports of harm relating to this issue.
Acción
William A Cook is advising customers to inspect stock and return affected product.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Getinge have identified a possible water leakage on limited washer disinfectors of model type wd15. if this issue occurs, both an acoustic and visual alarm ("a03 over flow co" on the machines display) will be present. this leakage may take place during operation in the last part of the cleaning and disinfection cycle. the leaking water has not been processed through the machine and from investigations it does not make contact with critical electrical components of the washer.If the issue is left unattended, there can be a leakage of cold water out from the water supply to the machine (up to 2 l/min). if users do not respond to the alarm, there may be a significant amount of water on the floor which may result in a person falling and acquiring an injury. there is also a risk for property damage from the water leak.To date, no injuries have been reported as a result of this issue.
Acción
Getinge are advising they are investigating this issue and will provide a solution as soon as it becomes available.
In the interim, users may continue to use the washer, provided that the machine is not left unattended.
Users should react to device alarms immediately.
If an alarm *A03 OVER FLOW CO* is activated, users are advised to do the following;
1. Switch off the main switch;
2. Close shut off valves in the water supply lines; and
3. Contact a service technician.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
There have been multiple vulnerabilities discovered in natus neuroworks software, which is used in natus xtek eeg medical products. the vulnerable devices contain an ethernet connection for data acquisition and connection to networks. under certain scenarios, these vulnerabilities allow a remote attacker to run arbitrary code on the device, including a denial of service attack.
Acción
Life Healthcare is advising that this issue is resolved in an updated software version - Neuroworks 8.5 GMA2. This software will be installed for users by Life Heathcare either on-site or via remote access depending on system setup.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Qiagen have identified an issue regarding the power branching printed circuit board (pcb) within the ez1 advanced xl instrument. occasionally this has the potential to trigger a malfunction of the instrument heater. nucleic acid extractions processed during failure of the instrument could be compromised and extractions need to be repeated.To date, no adverse events have been reported as a result of this issue.
Acción
Qiagen are advising they will replace the faulty component in all potentially affected instruments.
Until devices have been corrected, users are advised to complete the following test after every run:
1. Put any EZ1 XL Card into the instrument;
2. Select “3” in the main menu to select test functions;
3. Press ”2” in the test screen to choose the “Temp” operation;
4. Set the temperature to “40.0” degrees;
5. Press “START”; then
Observe the “actual” temperature which is displayed. This should rise to 40.0 C +/- 2 degrees within 2 minutes, and an “O” should be displayed next to the temperature value.
In the event that the “actual” temperature does not rise to 40.0 C, an “X” continues to be displayed next to the temperature value, this indicates that the instrument is affected by this issue. In this case the nucleic acid eluate from the previous run should be rejected and the sample reprocessed.
Contact technical services to arrange a replacement of the faulty component.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Getinge has received complaints involving the cardiosave iabps regarding ingress of fluids into the iabp affecting various electronic circuit boards. this situation would prevent initiation or continuation of therapy. to date, getinge has received one report of an adverse event in which one death was associated with a saline spill / liquid ingress.
Acción
Getinge are advising that affected sites will be contacted to schedule an on-site service of the Cardiosave IABP to install a protective top cover and perform a System Functional Test.
Until Getinge have implemented the corrective actions above, users should adhere to the instructions outlined on the Customer Letter when using the Cardiosave IABP
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Ortho clinical diagnostics australia has identified the potential for positively biased sample results to occur when using certain vitros na+ slides. results for serum/plasma and urine samples obtained using impacted vitros na+ slides may be positively biased and quality control fluids may be outside of the expected ranges. the amount of bias in the vitros na+ method is dependent upon multiple sources of variability.Two separate issues have been identified:- vitros na+ slides, gens 8 & 13: positively biased urine sample results; and - vitros na+ slides, gens 13, 14, 16, 17 & 18: positively biased serum or plasma sample results.
Acción
Ortho Clinical Diagnostics is advising:
For VITROS Na+ Slides, GENs 8 & 13:
- Discontinue using and discard all remaining inventory of VITROS Na+ Slides, GENs 8 & 13, regardless of sample type used for testing.
For VITROS Na+ Slides, GENs 14, 16, 17 & 18:
- Discontinue using and discard all remaining inventory of VITROS Na+ Slides, GENs 14, 16, 17 & 18, regardless of sample type used for testing.
- It is acceptable to continue to use remaining slides until your replacement order arrives provided both of the following criteria are met:
1. Calibration is successful and Quality Control results are within acceptable limits; and
2. Distribution of normal results for serum or plasma samples are centred within the established reference interval for the laboratory.
If at any time during use of remaining slides, any of the above criteria are no longer met, discontinue use and notify the requesting physician for all previously reported Na+ results that are likely affected where applicable.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The footplate of the patient support for stitching can be fixed in upper position. philips has identified that when the fixing clamp (hook) is not in its correct locking position, the footplate is not securely held. if it falls down, it may hurt the operators or patient's foot or leg (e.G. when moving the stand or when the operator fails to fix it correctly upon moving the footplate up). the following factors are needed for this situation to occur:- hinges are worn differently on both sides;- hook does not hold;- the operator does not check that the hook securely holds the footplate;- the footplate falls unexpectedly when touched or during transport;- foot or leg is in the “target area”; and/or- foot is in the “hazard area”.
Acción
Philips is advising that they plan make the following design changes:
- Sturdier replacement hinges for floor plate;
- Install modified hook for floor plate (adapted to new hinges); and
- The brake cylinder below floor plate to minimise kinetic energy.
A Philips service engineer will contact impacted customers as soon as the Field Action Kit is available to be implemented.
In the interim, users are advised to always ensure the correct positioning of the hook and that it is locked in accordance with the Instructions for Use (press hook down until it is locked).
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
In january 2014, smith & nephew issued a hazard alert for the journey bcs knee system (tga ref: rc-2014-rn-00004-1) which informed surgeons of the higher than expected revision rate identified by the aoanjrr and advised of the withdrawal of the journey bcs femoral component for primary surgery from the australian market.Smith & nephew is now issuing an update following an analysis of the national joint registry of england, wales & northern ireland (njrewni) & australian orthopaedic association national joint replacement registry (aoanjrr) data on the 1st generation journey bcs knee system.The journey bcs tibial insert remains available for use but should only be used for polyethylene exchange revision of first generation journey bcs total knee constructs where the femoral component and tibial baseplate are well fixed.
Acción
Surgeons should maintain their routine follow-up protocol for patients who have undergone total knee arthroplasty. Signs and symptoms to consider for potential revisions are no different from those that might be reported by any patient having undergone primary total knee arthroplasty. The need for revision should be determined on a case-by-case basis following a detailed assessment of each patient’s clinical circumstances. Smith & Nephew is not recommending pro-active revision surgeries for patients implanted with this device.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Elekta has identified that the margin tool in leksell gammaplan 11.1 systematically overestimates margin in certain areas of the volume. the root cause is that the margin algorithm calculates the expanded volume at a resolution limited to the original images resolution in the contours normal direction, resulting in an overestimation of the resulting margin volume in areas oblique to the contouring plane.
Acción
Elekta is requesting users consider implications of the described inaccuracy in use of the margin tool in Leksell GammaPlan.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
The manufacturer olympus winter & ibe has updated section 7.9.1 gas sterilisation in the instructions for use for the wair100a and wair130a to include the following warning:“warningrisk of injury to the patient and usertoxic gasses can enter internal volumes of the product during gas sterilisation. the gasses can remain in the product and can leak out during use.· to remove toxic gasses, aerate the product sufficiently after sterilisation.”.
Acción
Olympus is requesting users:
1. Inspect their inventory for any WAIR100A or WAIR130A Infrared Telescopes within their control;
2. Remove any existing Instructions for Use (IFU) and implement use of the updated IFU;
3. Ensure all reprocessing personnel are informed of the additional warning. Please do not hesitate to contact your local Olympus Sales Specialist to organise additional training;
4. Complete the reply form supplied with the customer letter and email to RA@Olympus.com.au or fax to 03 9562 6438; and
5. If you have distributed or transferred any of the affected products from your facility to another, forward the recall letter to them and notify Olympus so that they can follow up with that facility directly.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Aidacare has identified a labelling error pertaining to electrical classification on the manufacturer id sticker – it is shown as class ii device when the device is class i. this mislabelling creates the potential for testing and tagging to be incorrectly administered on fl250 beds.The class is labelled correctly on the control unit under the bed.
Acción
Aidacare is advising that they will contact impacted customers to arrange for on-site correction.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Medtronic has identified the potential for loss of high voltage and anti-tachycardia pacing therapy in entrust implantable cardioverter defibrillators (icds) as they near elective replacement indicator (eri) voltage. affected devices may display an immediate “end of life” (eol) observation with no prior alert (implanted electronic heart devices are designed to alert physicians and patients as the device battery depletes). though no elective replacement indicator (eri) alert is triggered, there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time eol observation. bradycardia (pacing) therapies will continue to operate as expected. medtronic has received no reports of patient deaths or serious adverse events due to this issue.
Acción
Medtronic is advising the below for surgeons following consultation with the Independent Physician Quality Panel:
- Schedule an in-office patient follow-up as soon as possible to assess the potential for this issue per the steps outlined in the Customer Letter.
- Ensure the Excessive Charge Time EOL…and the Low Battery Voltage ERI… Patient Alerts have been programmed to “On-High”.
- Instruct patients to contact your office if they hear device alert tones. Consider utilising the “Demonstrate Tones. . .” function to ensure patients recognise the audible tone.
- If this issue has occurred, an “EOL: replace device immediately” Observation will be displayed on the QuickLook report. Schedule device replacement immediately.
The Customer Letter provides information for surgeons to ensure high voltage therapy remains as the device battery voltage approaches its 2.61V ERI threshold.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Device technologies australia (dta) has been made aware by the manufacturer, vygon gmbh & co kg, of reported incidents where the stylet snapped upon removal when the user made a second attempt to remove the stylet from the catheter.
Acción
DTA is advising that the Instructions for Use (IFU) have been revised to provide further instructions concerning the removal of the Stylet.
The relevant segment is as follows:
"If difficulty is experienced removing the stylet stop, let vein rest for a minute and try removal again very slowly. Gentle flushing of the catheter with diluted lipid solution (preferred) or saline assists in stylet removal. If resistance still remains, withdraw catheter and stylet simultaneously".
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Medtronic has identified an issue in apple ios 11.3 & 11.4 that can sometimes prevent patients from receiving a 'lost communication' alert after their guardian connect app is closed by the iphone's operating system (ios) in certain situations. the operating system may close the guardian connect app without alerting patients that the app is no longer running or communicating with the guardian connect transmitter. if the app is closed, patients will not receive alerts that could be associated with hypoglycaemic or hyperglycaemic events. medtronic have received reports from patients regarding the app closing without warning, however, to date, no reports of injury as a result of this issue have been received.
Acción
Medtronic is advising users to immediately update their Guardian Connect App to the latest release (v3.2.2) located on the App Store.
Medtronic also reminds users that as described in the App User Guide, Medtronic cannot guarantee that iPhones will always allow for the Guardian Connect App to run in the background. If the iPhone automatically closes your Guardian Connect App, users may receive a ‘Lost Communication’ alert. To ensure users continue receiving sensor glucose data and alerts, Medtronic recommends periodically checking that the Guardian Connect App is still running, being especially mindful of this anomaly when running several applications at once or after using gaming and video Apps which use a lot of the iPhone’s power or memory resources.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Medtronic have identified that when an ap-vs interval measures 100-109ms during a short, nightly device check, a single reset is generated. this reset produces a non-programmable, wireless carealert, but does not alter device therapy. if the device experiences more than five resets due to this timing sequence between in-clinic device interrogations, a full reset (sometimes referred to as a power on reset) will occur. by design, a full reset automatically reverts device operation to rv-only pacing at vvi/65 until the next programmer session is conducted – at which time the full reset condition can be cleared, and the device can be reprogrammed to its prior settings.
Acción
Medtronic are advising that a software update, Application SW040 Version 8.1, is available for installation onto all CareLink Model 2090 and Encore programmers to eliminate this issue. Once installed, an in-clinic device interrogation will update the patient's device automatically to prevent this timing interaction from generating a reset.
Surgeons are advised:
- To contact their local Medtronic Representative to schedule installation of the updated Percepta CRT-P Application Software onto Medtronic 2090 and Encore Programmers.
- For a patient who has been implanted with a Percepta CRT-P device, consider scheduling an in-clinic device interrogation as soon as possible following installation of the updated application software, for the patient’s device to receive the automatic update.
Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
Notas adicionales en la data
Causa
Device technologies australia (dta) has been made aware by the manufacturer, vygon gmbh & co kg, of reported incidents where the stylet snapped upon removal when the user made a second attempt to remove the stylet from the catheter.
Acción
DTA is advising that the Instructions for Use (IFU) has been revised to provide further instructions concerning the removal of the Stylet.
The relevant segment is as follows:
"In order to remove the stylet, disconnect between the T-Piece and catheter hub. If difficulty is experienced stop, let vein rest for a minute and try removal again very slowly. Gentle flushing of the catheter with diluted lipid solution (preferred) or saline assists in stylet removal. If resistance still remains, withdraw catheter and stylet simultaneously."