Events

Alerte Ou Avis De Sécurité sur Turning aids: ReTurn 7400 and ReTurn 7500

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Handicare AB.

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
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2014/025
  • Numéro de l'événement
    CON432862
  • Date
    2014-07-02
  • Date de publication de l'événement
    2014-07-02
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON432862?tabName=allTabs
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Notes supplémentaires dans les données
  • Cause
    The wing handle on the ladder part of the turning aid may become loose, with a risk of harm to the patient and the person operating the device. the manufacturer has developed an inspection protocol, which is set out in its field safety notice (fsn) dated 19 march 2014. handicare has not had sufficient confirmation from users that they have received and acted upon the information contained in the fsn.
  • Action
    Identify any affected devices as described in the Field Safety Notice. Where appropriate, remove affected components and contact Handicare for replacements. If you service or recondition these devices, make sure you use the latest version of the service manual to inspect the wing handles, catches and ladders.

Device

Turning aids: ReTurn 7400 and ReTurn 7500
  • Modèle / numéro de série
  • Description du dispositif
    Turning aids: ReTurn 7400 and ReTurn 7500. Specific design is affected. What is affected: The spare part 'wing handles', article number 7322, delivered from June 2009 to July 2011 inclusive. Any ReTurn 7400 or ReTurn 7500 with the ladder attached to the chassis, delivered until May 2011, might have the affected wing handle (see FSN for further details).
  • Manufacturer
    Handicare AB

Manufacturer

Handicare AB