Events

Alerte De Sécurité sur HeartStart MRx Monitor/Defibrillator with Q-CPR

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.

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
    2015-09-01
  • Date de publication de l'événement
    2015-09-01
  • 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_20150901a.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 with q-cpr medical device manufacturer, philips, has issued a medical device safety alert concerning its heartstart mrx monitor/defibrillator with q-cpr. the affected devices are identified as follows:-  units affected: all q-cpr meter and cpr sensor;  model number: 453564145481, 453564257691 and m4761a during internal review, the manufacturer identified that the instructions on attaching the q-cpr meter adhesive pad to the q-cpr meter could be improved. in addition, instructions did not inform the users that properly performed cpr can result in injuries to the patient. the manufacturer has updated the heartstart mrx’s instructions for use associated with q-cpr sensor via an addendum. the addendum has instructions on application of the disposable adhesive pads, which are used with the q-cpr meter, including a diagram which illustrates proper placement and orientation of this pad. in addition, the addendum includes general information on the types of injuries, which may occur during cpr. according to the local supplier, the q-cpr meter and cpr sensor are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 1 september 2015.

Device

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

Manufacturer

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