Alerta De Seguridad para GemStar Power Supply 3VDC

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Hospira.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
  • Fecha de publicación del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    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.



  • Empresa matriz del fabricante (2017)
  • Source