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HEARTSTART MRX DEFIBRILLATOR/MONITOR (2017-09-27)
- Starting date:
- September 27, 2017
- Posting date:
- October 13, 2017
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- Healthcare Professionals, General Public, Hospitals
- Identification number:
- RA-64846
Affected products
HEARTSTART MRX DEFIBRILLATOR/MONITOR
Reason
It was determined that 20 HeartStart MRx Defibrillator/monitors were affected by the same organic contamination clogging the 9 um filter in the zero line of the EtCO2 module.
This issue may expose a patient to a hazardous situation because:
- A capnogram is not displayed and that may result in unrecognized intubation/ventilation issues
- CO2/respiratory rate monitoring is unavailable
- EtCO2 will not be displayed, necessitating that the user rely on other parameters to adjust ventilation rate and depth.
Affected products
HEARTSTART MRX DEFIBRILLATOR/MONITOR
Lot or serial number
All lots
Model or catalog number
M3536A
Companies
- Manufacturer
-
Philips Medical Systems
3000 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES