Events

Recall of Lifepak15 Monitor/Defibrillator with End-tidal CO2 Option

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Physio-Control Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-01482-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01482-1
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DHTGA