Events

Rappel de Philips IntelliVue Neuromuscular Transmission (NMT) Patient Cables (Used with Philips IntelliVue NMT Module 865383 and IntelliVue Patient Monitors)

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-00629-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-05-19
  • 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-00629-1
  • 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
    Investigations conducted by philips subsequent to customer complaints have revealed that a small number of intellivue neuromuscular transmission (nmt) patient cables may contain a localised isolation defect in the shielding of the acceleration sensor housing. this manufacturing defect may cause localised heating due to an unintended current flow between the acceleration sensor housing attached to the patient thumb and the nmt stimulation electrode connection attached to the wrist of the same hand. using a defective nmt patient cable on a patient under anaesthesia who receives repeated nmt stimulations during a procedure may result in a localised skin burn of up to several millimetres in diameter.
  • Action
    Philips is requesting customers to identify all affected cables by checking their inventory for NMT patient cables that bear the CE mark with the suffix "0366". The affected stock is to be removed from inventory and quarantined. Customers will be contacted by a Philips Healthcare representative or an authorised service provider to arrange for a visit to replace the affected cables.

Device

Philips IntelliVue Neuromuscular Transmission (NMT) Patient Cables (Used with Philips IntelliVue ...
  • Modèle / numéro de série
    Philips IntelliVue Neuromuscular Transmission (NMT) Patient Cables (Used with Philips IntelliVue NMT Module 865383 and IntelliVue Patient Monitors)Philips IntelliVue NMT Patient CablesModel: 989803174581Cable also supplied in Philips IntelliVue NMT Module, Product Option #K01, Model : 865383 #K01 Cables that have CE Mark with suffix 0366 ARTG Number: 202378
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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