Events

Alerte De Sécurité sur Carry Case used with the HeartStart FR3 Automated external defibrillator (AED)

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
    2012-03-06
  • 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_20120306a.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
    Field safety notice: carry case used with the heartstart fr3 automated external defibrillator (aed) the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning the carry case used with heartstart fr3 aed, manufactured by philips healthcare. according to the manufacturer, the heartstart fr3 aed itself is not part of this action. only the small soft carry cases [model numbers 989803173711 (philips) and 989803173721 (laerdal)] manufactured by philips and shipped between may 2011 and august 2011 are part of this action. all small soft cases, models 989803173711and 989803173721, are affected. the model number can be found on the carry case label, located directly under the fr3 when it is stored in the case. the affected small soft carry cases incorporate a magnet in the lid that automatically turns the fr3 aed on when the case is opened. if the case is not aligned properly when closed, the fr3 may interpret the resulting intermittent misalignment of the magnet as a case opening. thus, the aed may turn on repeatedly while stored in the case, inadvertently depleting the battery. the manufacturer warned users that a drained battery may not allow the fr3 to deliver therapy in case of an emergency. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm according to the local supplier, the affected device has not been distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.

Device

Carry Case used with the HeartStart FR3 Automated external defibrillator (AED)
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Carry Case used with the HeartStart FR3 Automated external defibrillator (AED)
  • Manufacturer
    Philips Healthcare

Manufacturer

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