Events

Alerte De Sécurité sur Physio-Control ADULT-EDGE Electrode with QUIK-COMBO Connector and REDI-PAK Preconnect

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 Inc..

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
    2016-02-16
  • Date de publication de l'événement
    2016-02-16
  • 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_20160216.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 adult-edge electrode with quik-combo connector and redi-pak preconnect the medicines and healthcare products regulatory agency (mhra) of united kingdom posted a medical device safety alert concerning adult-edge electrode with quik-combo connector and redi-pak preconnect manufactured by physio-control inc. [catalogue number: 11996-000017; min number: 3202674-005; lot numbers: 516907, 519815, 519816]. the manufacturer conducted a voluntary recall of the abovementioned product due to a low-level potential for damage to the wire insulation during the manufacturing process of these specific lots. the defibrillation electrodes used in conjunction with certain physio-control lifepakr products. the use of products with this condition may result in a potentially increased risk for reduced or no patient therapy, arcing of current, sparking, and patient and/or clinician bum. the manufacturer advises customers to quarantine the affected products and return them to the manufacturer. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 16 february 2016.

Device

Physio-Control ADULT-EDGE Electrode with QUIK-COMBO Connector and REDI-PAK Preconnect
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Physio-Control ADULT-EDGE Electrode with QUIK-COMBO Connector and REDI-PAK Preconnect
  • Manufacturer
    Physio-Control Inc.

Manufacturer

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