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 Medical Systems.

¿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
    2013-04-19
  • Fecha de publicación del evento
    2013-04-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130419a.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 medical device manufacturer, philips healthcare, has issued a field safety notice concerning heartstart mrx monitor/defibrillator [model no.: m3535a, m3536a, m3536j, m3536m, m3536mc, m3536m2, m3536m4, m3536m5, m3536m6; serial numbers within the range us00100100 to us00565942] according to the manufacturer, the philips heartstart mrx monitor/defibrillator may fail to deliver defibrillation therapy in either manual defib or aed mode. if this occurs, the mrx may simultaneously display a “no shock delivered” message along with a “shock equip malfunction”, inop and a red x in the rfu indicator. in addition, the pads ecg waveform may display a non-physiologic flat line rhythm. if the problem occurs, there may be a failure to deliver shock therapy to a patient in need of defibrillation or cardioversion therapy. the manufacturer will provide software upgrade to fix the problem. however, prior to performing the software upgrade, the manufacturer recommends customer to follow step 1. step 1: if the problem occurs, disregard the mrx “no shock delivered”, “shock equip malfunction”, inop and the red x. press the lead select button to display another ecg waveform and continue to administer additional shock therapy as needed. if step 1 does not resolve the problem follow step 2. step 2: treat your patient per existing protocols. if possible, philips recommends that a backup defibrillator be made available. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 april 2013.

Device

HeartStart MRx Monitor/Defibrillator
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Philips Medical Systems HeartStart MRx Monitor/Defibrillator
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    DH