Events

Alerte De Sécurité sur HeartStart MRx Monitor/Defibrillator

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Philips Medical Systems.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2014-02-26
  • Date de publication de l'événement
    2014-02-26
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140226.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: philips heartstart mrx monitor/defibrillator medical device manufacturer, philips healthcare, has issued a field safety notice (fsn) concerning heartstart mrx monitor/defibrillator. the affected model numbers are m3535a, m3536a, m3536j, m3536m, m3536m5, and m3536mc, and the affected serial numbers are within the range us00100100 - us00550668. the ecg trunk cable and connector block of the mrx could be susceptible to accelerated wear, which could result in an interrupted ecg signal. interruption of the ecg signal can cause loss of demand mode pacing, inability to perform synchronized cardioversion with paddles, and disruption of leads ecg monitoring, which could delay appropriate treatment. defibrillation, fixed mode pacing, ecg monitoring via pads/paddles, and other monitoring functions are not impacted by this issue. the manufacturer will provide a hardware upgrade on all affected units. users can continue to use mrx prior to receiving the hardware upgrade. if the above problem occurs, users should refer to the heartstart mrx instructions for use for troubleshooting assistance and follow the technical advice as listed in the fsn. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 26 february 2014.

Device

HeartStart MRx Monitor/Defibrillator
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Philips Medical Systems HeartStart MRx Monitor/Defibrillator
  • Manufacturer
    Philips Medical Systems

Manufacturer

Philips Medical Systems
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DH