Events

Avis De Sécurité sur Ceiling Supply Unit klinoPORT

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 TRUMPF Medizin Systeme GmbH + Co. KG.

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
    2015-06-24
  • 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
    Trumpf medical was informed of an event where the motorised height-adjustable arm of a klinoport ceiling supply unit suddenly and abruptly fell to its lowest position. the cause analysis revealed that the welded connections of the drive did not comply with the specified condition and therefore led to breakage of these connections. it is currently not to be ruled out that further drives within the same serial numbers range may have the same fault. if further cases should occur, the risk of severe injury to persons cannot be ruled out. .

Device

Ceiling Supply Unit klinoPORT

Manufacturer

TRUMPF Medizin Systeme GmbH + Co. KG