Events

Alerte De Sécurité sur heartstart mrx monitor/defibrillators

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 Healthcare.

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
    2013-06-20
  • Date de publication de l'événement
    2013-06-20
  • 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_20130620a.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/defibrillators the australia therapeutic goods administration (tga) has posted a medical device safety alert concerning certain models of heartstart mrx monitor/defibrillators [model no.: m3535a, m3536a, m3536j, m3536m, m3536mc, m3536m2, m3536m4, m3536m5, m3536m6], manufactured by philips healthcare. the affected units include those manufactured by philips between february 2004 and may 2013, and with serial numbers between us00100100 to us00567299. a philips heartstart mrx monitor/defibrillator could deliver a non-synchronised cardioversion shock when the user rotates the therapy knob while simultaneously pressing the sync button, then charges the mrx and presses the shock button. delivery of a non-synchronised cardioversion shock could result in the delivery of incorrect therapy, which may induce ventricular fibrillation. additionally, the label affixed to the top of the mrx device is not consistent with the instructions for use. the manufacturer is providing work around instructions as an interim measure. a software update and device label revision will be supplied to users as a permanent fix. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-00622-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 june 2013.

Device

heartstart mrx monitor/defibrillators
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Philips HeartStart MRx Monitor/Defibrillators
  • Manufacturer
    Philips Healthcare

Manufacturer

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