Events

Avis De Sécurité sur Stryker Model 6100 M1 Ambulance Cot

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

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
    SN2010(012)
  • Date
    2010-09-30
  • 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=/stryker-model-6100-m1-ambulance-cot&id=6d8af825-9782-6eee-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
    Stryker has become aware that the head end slide tube, bushings and head end release rod of the model 6100 m1 ambulance cot can break during use, potentially resulting in the head end of the cot collapsing.
  • Action
    As there are no sales records, the IMB are requesting that healthcare workers contact Stryker UK if they are aware that this device has been distributed in Ireland.  If affected devices are located at your facility and the unit does not operate properly, remove the unit from service and contact Stryker UK to arrange for a device retrofit / upgrade. The attached field safety notice issued by Stryker provides further information on this issue.

Device

Stryker Model 6100 M1 Ambulance Cot
  • Modèle / numéro de série
  • Description du dispositif
    Stryker Model 6100 M1 Ambulance Cot
  • Manufacturer
    Stryker Medical

Manufacturer

Stryker Medical
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    HPRA