Events

Avis De Sécurité sur Jarvik 2000 Ventricular Assist System, Adult VAD, Post-Auricular Cable Model, JHl-001

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Jarvik Heart, Inc..

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
    2017-07-21
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Jarvik heart, inc. has been requested by the french competent authority, ansm, to issue a field safety corrective action (fsca) based on two (2) incidents involving disconnection of the pedestal cable (jhi-201) resulting from the use of oily or fatty substances near the pedestal connector. both of these disconnections occurred in a hospital environment, activated an alarm. and were promptly addressed by a clinician re-connecting the cable with no harm to the patient. the cable was later replaced. jarvik heart, inc. is aware of only two (2) reportable incidents of this type in over five hundred (500) implants of the post-auricular cable, jhi-001. based on the reported events, the occurrence rate for this type of incident is 0.4%. .

Device

Jarvik 2000 Ventricular Assist System, Adult VAD, Post-Auricular Cable Model, JHl-001

Manufacturer

Jarvik Heart, Inc.