Events

Rappel de Lifepak15 Monitor/Defibrillator with End-tidal CO2 Option

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Physio-Control 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-2016-RN-01482-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-11-11
  • 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-2016-RN-01482-1
  • 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
    Physio-control has become aware that the display of the lifepak 15 respiratory rate may partially obscure a portion of the leading digit of the etco2 value when using etco2 in the kpa or % setting mode and in a situation where the reading is above 9.9 kpa. although only part of the first digit of the etco2 value is obscured by the respiratory rate, the capnography waveform scale automatically adapts to the etco2 value. observing the capnography waveform and the range displayed will help the user confirm the patient’s etco2 value. clinical misinterpretation of a low etco2 value when the value is actually high could potentially lead to incorrect treatment and/or delays in clinical decision making. there have been no reports of incorrect patient treatment or harm associated with this issue.
  • Action
    Physio-Control is requesting users to:- 1. Forward this information to all associated sites, trainers and users that may have a LIFEPAK 15 monitor/defibrillator; 2. In the event staff use LIFEPAK 15 monitor/defibrillator to display EtCO2 values they should also display the EtCO2 waveform which includes the range along the right side of the display; 3. In the event staff use either kPa or % settings, they should activate EtCO2 alarms to identify EtCO2 values outside the normal range; and 4. If local protocols allow this option, consider changing the EtCO2 to measure in the mmHg setting. Once a permanent correction is developed Physio-Control will post information on our website when an updated software version is available.

Device

Lifepak15 Monitor/Defibrillator with End-tidal CO2 Option

Manufacturer

Physio-Control Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA