Events

Rappel de INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE - BABYLOG VN500

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par DRAEGERWERK AG & CO. KGAA.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    15486
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-07-08
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Draeger became aware about an event in which the battery capacity of the optional ps500 of an iacs workstation critical care (evita infinity v500) did not last as long as expected. the batteries installed in the ps500 depleted much earlier than expected although the battery indicator showed a sufficiently charged battery. the sequential alarms "battery low" followed by "batter depleated" were given however the remaining time until the ventilator shut down was not foreseeable. when the battery depleted totally the power fail alarm was generated. draeger issued a measure in february 2014 and july 2014 regarding battery capacity failures. the root cause for the reduced battery capacity at that time was due to an incorrect charging algorithm that subsequently caused sulfation within the battery. the new battery that was exchanged with that corrective action was tested and qualified. however draeger has learned from the supplier that the batteries of this lot may be affected by a manufacturing defect that may lead to shorter battery life times. as a consequence draeger has decided to replace all batteries for the ps500 again.

Device

INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE - BABYLOG VN500
  • Modèle / numéro de série
    Model Catalog: 8415000 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Description du dispositif
    INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE - BABYLOG VN500
  • Manufacturer
    DRAEGERWERK AG & CO. KGAA

Manufacturer

DRAEGERWERK AG & CO. KGAA