Events

Alerte De Sécurité sur heartstart xl defibrillator/monitor with m3516a batteries

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
    2013-08-16
  • Date de publication de l'événement
    2013-08-16
  • 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_20130816b.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 xl defibrillator/monitor with m3516a batteries the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) issued a medical device alert concerning heartstart xl defibrillator/monitor with m3516a batteries of lot number with ‘lk’ prefix manufactured by philips healthcare. theaccording to the mhra, defibrillator battery life has been reduced from 1.5 years to 1 year and the capacity test interval has been reduced from six months to three months. this applies to new batteries with the lot number prefix ‘lk’. the mhra clarifies that philips heartstart xl batteries with lot code prefixes ‘p’, ‘r’, and ‘pcs’ are not affected by this change and continue to have a life expectancy of about 1.5 years, when properly maintained and stored, and battery capacity test intervals of 6 months (for infrequent use) or 3 months (for frequent use). these batteries are still supported with relevant instructions for use and labelling. philips is supplying an addendum (see appendix of the alert) with battery orders and heartstart xl monitor/defibrillator orders stating the changes to heartstart xl instructions for use (edition 7) and heartstart xl service manual (edition 6). the mhra provides the following advice to the affected users: ensure all relevant staff are aware of the changes. ensure that the addendum is attached to the instructions for use and service manuals accordingly. be aware that this addendum supersedes any previous guidance given by philips regarding battery life and capacity test frequency. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/publications/safetywarnings/medicaldevicealerts/con305480 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 august 2013.

Device

heartstart xl defibrillator/monitor with m3516a batteries
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Philips HeartStart XL defibrillator/monitor with M3516A batteries
  • Manufacturer
    Philips Healthcare

Manufacturer

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