Events

Rappel de Panda iRes Warmers integrated with Nellcor SpO2

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par GE Healthcare Australia Pty 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-2014-RN-00450-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-04-16
  • 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-2014-RN-00450-1
  • 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
    There may be a loss of internal communication that manages the user-adjusted nellcor spo2 alarm settings of the affected giraffe and panda ires warmer systems with nellcor spo2 listed above. if the issue exists, the alarms may not activate as expected, which can result in false positive or false negative saturation and pulse rate alarm notifications to the caregiver. the patient’s oxygen saturation and pulse rate values are accurate, as displayed; however, the displayed user-set alarm limits may be different than the actual alarm limits used for alarm activation. all other clinical functionality of the warmer is unaffected.This alarm failure is caused by a software issue that does not detect a loss of internal communication that manages the user-adjusted nellcor spo2 alarm settings.
  • Action
    GE Healthcare will correct all affected systems with a software revision. Customers may continue to use the system provided they follow the GE recommended actions as follows: 1) If in use with a patient, turn off the Nellcor SpO2 function in the control panel and switch to an approved alternate form of SpO2 measurement. 2) Prior to using the affected GE warmer with the Nellcor SpO2 function, or resuming the use of this function with any patient, contact hospital Bio-Med or qualified technician to check the Nellcor SpO2 alarm functionality using either an adult Nellcor SpO2 sensor or a Nellcor SpO2 simulator. 3) If the test activates a ‘Low Pulse Rate’ alarm, the user-adjusted Nellcor SpO2 alarm limits are functioning properly and the warmer can be placed back in clinical service. PLEASE NOTE: Alarm functionality must be re-checked following every service event requiring access to the internal electronics and during annual preventative maintenance, until revised software is installed. 4) If the test does NOT activate a ‘Low Pulse Rate’ alarm, remove the warmer from clinical service and contact your local GE Healthcare Service Representative.

Device

Panda iRes Warmers integrated with Nellcor SpO2

Manufacturer

GE Healthcare Australia Pty Ltd