Events

Avis De Sécurité sur Cervical Halo Traction Apparatus

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Jerome 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
    SN2004(02)
  • Date
    2004-03-12
  • 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=/cervical-halo-traction-apparatus&id=8895f825-9782-6eee-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
    The potential for imaging problems ranging from artifact, sparking, vibration, patient discomfort and / or surface burns when the cervical halo device is worn during a mri scan.
  • Action
    Ensure that all devices that are sold as single use devices are only use once Ensure that MRI compatible devices are configured and positioned in the MRI so as to ensure that they are not too close to the MRI core and that metal components are not  criss-crossing or concentrated in one area  Ensure that the use of all MRI compatible devices are reviewed when any changes are made to the MRI strength to ensure that they still remain compatible  Ensure that patients screening forms are completed for all patients. (see form attached checklist) Report any indications of problems to the IMB

Device

Cervical Halo Traction Apparatus
  • Modèle / numéro de série
  • Description du dispositif
    Cervical Halo Traction Apparatus
  • Manufacturer
    Jerome Medical

Manufacturer

Jerome Medical
  • Société-mère du fabricant (2017)
    Össur hf
  • Source
    HPRA