Events

Avis De Sécurité sur Contoura 880 Beds

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

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
  • Date
    2009-08-21
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/contoura-880-beds&id=de8cf825-9782-6eee-9b55-ff00008c97d0
  • 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
    Some bed rail support brackets have been found to have poor welds causing them to fail in use. patients are at risk of injury from a fall if the bed rails fail in use.
  • Action
    1) Ensure the appropriate personnel are made aware of this notice.  2) Identify the location of all Contoura 880 beds.  3) Determine if your institution has devices affected by this issue.  This can be determined by:       A) Checking the manufacturing date to see if it is between December 1999 and June 2001.       B) Checking if the Serial number lies in the range 167386 to 382938.  4) Check the support bracket on the frame and if cracking is found contact the manufacturer who will provide and fit replacement brackets free of charge.  5) Ensure that correction is completed on all affected devices.

Device

Contoura 880 Beds

Manufacturer

Huntleigh Healthcare Ltd
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    HPRA