Events

Rappel de Philips Sync Cables and Philips ECG Out Cables

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Philips Electronics Australia 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
    RC-2017-RN-00900-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-07-21
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00900-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Philips originally advised of electrical interference via sync cables (tga ref: rc-2014-rn-01291-1), where affected cables were replaced. philips is now advising users to cease using and dispose of sync cables and ecg out cables, as when using a sync cable or ecg out cable with the heartstart mrx or heartstart xl, eft noise may be mistaken as an r-wave. if this occurs when performing synchronised cardioversion, there is a potential for inducing ventricular fibrillation if shocks are synchronised to eft noise instead of the r-wave of the patient’s actual ecg.
  • Action
    Philips is requesting users read the supplied notice and then: 1. Remove affected sync cables and ECG out cables from service and destroy them, documenting such action on the acknowledgement form, which should be returned to Philips; 2. There are 3 options for the user to synchronise the MRx or XL+ monitor/defibrillators, so the synchronisation function is not lost. In summary, these methods are: -The shock pads ECG can be used for synchronisation. -If the user places or replaced 3 leads ECG pads, the resulting ECG can be used for synchronisation. -The ECG trunk cable can be disconnected from the Philips bedside monitor and connected to the monitor/defibrillator before delivering therapy. For further information, the customer should refer to the Instructions for Use that describe the recommended approach for performing cardioversion.

Device

Philips Sync Cables and Philips ECG Out Cables
  • Modèle / numéro de série
    Philips Sync Cables and Philips ECG Out CablesPhilips Sync CablesModel Numbers: M1783A and M5526AECG Out CablesModel Number: 989803195641ARTG Number: 95661
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DHTGA