Events

Alerta De Seguridad para HeartStart MRx monitor/defibrillator

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Philips Healthcare.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2012-08-08
  • Fecha de publicación del evento
    2012-08-07
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120808.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: philips heartstart mrx monitor/defibrillator health canada posted a medical device safety alert concerning heartstart mrx monitor/defibrillator (model no.: m3535a, m3536a), manufactured by philips medical systems. according to the report, the manufacturer has become aware that affected devices may exhibit the following behaviors: in aed mode the device experiences difficulty interpreting pads ecg waveforms and may incorrectly analyze the waveform (potential for inappropriate therapy) or fail to analyze the waveform. in manual mode the user may have trouble interpreting the pads ecg waveform and determining whether or not to deliver therapy in addition the devive may provide erroneous alarms (e.G. pvc/min high, vtach, asystole) or indicate an asystolic rhythm when paddles are not in patient contact. if cpr meter is in use, users may not get an accurate impedance derived ventilation feedback. for details, please refer to the health canada website http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/ _list/rec-ret_md-im_date_july-sept_2012-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 7 august 2012.

Device

HeartStart MRx monitor/defibrillator
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips HeartStart MRx monitor/defibrillator
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH