Avis De Sécurité sur Mobile Patient Lifts - Uno, Viking S, Viking XS, LikoLight

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Hill-Rom.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Numéro de l'événement
    SN2011(23)
  • Date
    2011-10-05
  • Pays de l'événement
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
  • Notes / Alertes
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland."
  • Notes supplémentaires dans les données
  • Cause
    Hill-rom is aware that a number of mobile patient lifts on the irish market may not yet have received an ‘outer tube’ accessory, which will prevent the actuator from collapsing in the event that it should malfunction.
  • Action
    Hill-Rom has been unsuccessful in their attempts to date to locate all devices in Ireland affected by this field safety corrective action.  The IMB advises that users:  1. Ensure the appropriate personnel are made aware of this notice.  2. Identify the location of all affected mobile patient lifts.  3. Determine if you / your institution have medical devices affected by this issue.  4. If you / your institution have affected medical devices, follow the manufacturer’s recommendations as outlined in the attached field safety notice and ensure that corrective action is completed on all affected medical devices.

Device

  • Modèle / numéro de série
  • Description du dispositif
    Mobile Patient Lifts - Uno, Viking S, Viking XS, LikoLight
  • Manufacturer

Manufacturer