Events

Alerte De Sécurité sur Physio-Control, LIFEPAK 20e Defibrillator/Monitor

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Physio-Control.

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
    2018-01-09
  • Date de publication de l'événement
    2017-01-09
  • 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_20180109b.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: physio-control, lifepak 20e defibrillator/monitor medical device manufacturer, physio-control, has issued a medical device safety alert concerning its lifepak 20e defibrillator/monitor [model/catalog numbers: 70507-xxxxxx, 99507-xxxxxx; lot number multiple]. the manufacturer is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. the symptoms of these failures may include unexpected power on and power off, device lock-up, or a failure to power on or off. according to the manufacturer, the failures are the result of the manufacturing process residue located beneath a component mounted on the power printed circuit board assembly (pcba). this has the potential to result in a failure to deliver therapy to the patient and serious injury or death. the manufacturer has not received any adverse events reported as a result of this issue. the manufacturer will contact potential affected users to arrange for a device correction included the replacement of the power pcba. the customers are requested to follow the recommended daily operator’s checklist steps in accordance with lifepak 20e defibrillator/monitor operating instructions – section 7 – maintaining the equipment. if the users experience any of the symptoms described above, contact the manufacturer immediately to arrange servicing to your device. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 09 january 2017.

Device

Physio-Control, LIFEPAK 20e Defibrillator/Monitor
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Physio-Control, LIFEPAK 20e Defibrillator/Monitor
  • Manufacturer
    Physio-Control

Manufacturer

Physio-Control
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DH