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Health product recall

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