Events

Alerte De Sécurité sur automated external defibrillator heartstart fr3

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
    2014-03-07
  • Date de publication de l'événement
    2014-03-07
  • 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_20140307a.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 healthcare automated external defibrillator heartstart fr3 medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning automated external defibrillator (aed) heartstart fr3 with model numbers 861388 and 861389. the affected products were manufactured from may to august 2013. according to philip healthcare, heartstart fr3 2.0 device software contains a defect which, in unlikely situations, may cause a unit to indicate that it is ready for use though its battery is low. an aed running affected software may not report its low battery condition until the unit is turned on, and consequently may be unable to maintain the power needed to deliver therapy in an emergency. the manufacturer advises users of the followings: if users have an affected device, they should remove it from service. users should upgrade all affected fr3 units according to the instructions in the fr3 software upgrade kit. according to the local supplier, the affected products were distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 07 march 2014.

Device

automated external defibrillator heartstart fr3
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Philips Healthcare Automated External Defibrillator HeartStart FR3
  • Manufacturer
    Philips Healthcare

Manufacturer

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