Events

Alerte De Sécurité sur IW900-series Infant Warmers

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Fisher & Paykel 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
    2014-11-06
  • Date de publication de l'événement
    2014-11-06
  • 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_20141106a.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: fisher & paykel healthcare iw900-series infant warmers it has come to our attention that medical device manufacturer, fisher & paykel healthcare, has initiated a field safety corrective action concerning some of its iw900-series infant warmers. there were two confirmed reports of breakage of the nut that secures the heater head in place. breakage of the nut can cause the heater head to become partially detached and swing towards the bassinet. the heater head did not contact the patient in either case, however there is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury. users should check whether they have the affected infant warmers and the spare parts. the manufacturer is supplying replacement pivot securing nuts to all affected customers. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 november 2014.

Device

IW900-series Infant Warmers
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Fisher & Paykel Healthcare IW900-series Infant Warmers
  • Manufacturer
    Fisher & Paykel Healthcare

Manufacturer

Fisher & Paykel Healthcare