Events

Alerte De Sécurité sur GemStar Power Supply 3VDC

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

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_20141106.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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: hospira gemstar power supply 3vdc the united states food and drug administration (fda) posted a medical device safety alert concerning gemstar power supply, 3vdc, manufactured by hospira.The affected devices are identified as follows: wall mount power supply [list number:13026-05] desk top power supply [list number:13072-05] according to the fda, the power supply may not properly deliver electric power to the gemstar infusion pump. if the power supply fails, planned infusion therapy may be delayed if a backup power supply is not used. the manufacturer received a total of 20 reported incidents including one report of smoke and found that the gemstar infusion pump was operating on battery power while connected to the 3vdc power supply. there were no reports of injuries or death. the manufacturer advises users to take the following precaution: avoid arcing, wiggling, or dropping the power supply on hard surfaces. doing so may result in internal damage that would stop the power supply from working. affected users are advised to remove the power supply from service. according to the manufacturer, there is no need to return fully functional power supplies (unless they malfunction). for details, please refer to the following fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm421951.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm421946.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 november 2014.

Device

GemStar Power Supply 3VDC

Manufacturer

Hospira
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    DH