This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
LIFEPAK 15 MONITOR/DEFIBRILLATOR
- Starting date:
- September 9, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-60538
Affected Products
Reason
Physio-Control, Inc. LIFEPAK 15 Monitor/Defibrillators with End-tidal(Et)CO2 capability are distributed with the EtCO2 setting preset to display in (millimeter of mercury) mmHg. Customers may choose to reconfigure the device to display the EtCO2, in alternative modes of (kilopascal) kPa or percent settings. When using EtCO2 in the kpa or percent setting and in a situation where the reading is above 9.9 kPa, the display of the LIFEPAK 15 respiratory rate may partially obscure a portion of the leading digit of the EtCO2 value. Although 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 interpretation of a low EtCO2 value when the value is actually high could potentially lead to incorrect treatment. There have been no reports of incorrect patient treatment or harm associated with this issue.
Affected products
LIFEPAK 15 MONITOR/DEFIBRILLATOR
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
99577-XXXXXX
Companies
- Manufacturer
-
Physio-Control, Inc.
11811 Willows Road North East
Redmond
98052
Washington
UNITED STATES