Events

Rappel de HEARTSTART XL+

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par PHILIPS ELECTRONICS LTD..

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
    59988
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-06-30
  • 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
    Through internal testing and customer complaint investigations the following xl+ software and hardware issues have been identified: software: 1. the xl+ may fail to complete the power on sequence and continuously reboot. 2.The xl+ may either fail to power up or may shut down unexpectedly. 3. the xl+ may have a software version that did not reset a fail-safe monitoring component which could delay of therapy or pacing interruption. 4. the xl+ may fail to generate verbal prompts in aed mode. hardware: a. the xl+ may have been manufactured with a speaker that may fail. b. the battery may not seat properly causing the xl+ to shut down unexpectedly or remain powered on and not acknowledge or charge the battery. c. the xl+ exceeds the allowable radiated emissions level for class b cispr11. d. the xl+ ecg signal from leads could be lost and unrecoverable. e. the xl+ spo2 signal may lose communication and cause the device to reboot. f. the xl+ battery detection system may be disrupted and cause a false low battery alarm.

Device

HEARTSTART XL+
  • Modèle / numéro de série
    Model Catalog: 861290 (Lot serial: >10 contact mfg.)
  • Description du dispositif
    HEARTSTART XL+
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Adresse du fabricant
    MARKHAM
  • Société-mère du fabricant (2017)
    Philips
  • Source
    HC