Events

Alerte De Sécurité sur Automated External Defibrillator HeartStart Home and Onsite (HS1)

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_20140307.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 home and onsite (hs1) medical device manufacturer, philips healthcare, has issued a medical device safety alert concerning automated external defibrillator (aed) heartstart home and onsite (hs1) with model numbers m5066a and m5068a. the affected products were manufactured in july 2013. according to the manufacturer, in a limited number of heartstart home and onsite (hs1) aeds, one or both contact pins may be contaminated by residue from the soldering process. this contamination could prevent an adequate connection between the pads cartridge and the aed. if poor contact between the pads cartridge and aed occurs, the device may be unable to deliver therapy in an emergency. the manufacturer will replace the affected aeds for their customers. meanwhile, users are advised to keep the aeds in service if there are no alternative defibrillators readily available. 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 Home and Onsite (HS1)
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Philips Healthcare Automated External Defibrillator HeartStart Home and Onsite (HS1)
  • Manufacturer
    Philips Healthcare

Manufacturer

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