Events

Avis De Sécurité sur Corona Medical Bed Side Rails – 1025, 1031 & SP 1027 Range

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Corona 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
    SN2011(29)
  • Date
    2011-11-28
  • 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=/corona-medical-bed-side-rails-1025-1031-sp-1027-range&id=3681f825-9782-6eee-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
    Corona medical bed side rails – 1025, 1031 & sp 1027 range are not compliant with the dimensional requirements of the applicable standards, which defines the minimum size and / or maximum areas with risk of trapping in an adult bed for medical use. these side rails require replacement.
  • Action
    Corona Medical and MMS Medical have 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 side rails.  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 FSN and ensure that corrective action is completed on all affected medical devices.

Device

Corona Medical Bed Side Rails – 1025, 1031 & SP 1027 Range
  • Modèle / numéro de série
  • Description du dispositif
    Corona Medical Bed Side Rails – 1025, 1031 & SP 1027 Range
  • Manufacturer
    Corona Medical

Manufacturer

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