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Heartstart MRX Defibrillator / Monitor and QCPR-CPR Meter Upgrade Kit (2014-02-26)
- Starting date:
- February 26, 2014
- Posting date:
- March 25, 2014
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-38597
Recalled Products
A. Heartstart MRX Defibrillator / Monitor
B. QCPR-CPR Meter Upgrade Kit
Reason
Philips has become aware of the following issues regarding the Heartstart MRX monitor/defibrillator:
when the Heartstart MRX is in AED mode, the Q-CPR meter is designed to display the 'Do not touch the patient' icon during the shock advisory analysis period. If the user continues to deliver chest compressions when the shock advisory analysis begins, the 'Do not touch the patient' icon may incorrectly remain on the screen after analysis or shock delivery is complete.
When the Heartstart MRX is in manual mode, the Q-CPR meter is designed to display the 'Do not touch the patient' icon when the device is charging to the selected energy. If the clinician continues to provide chest compressions while the device is charging, the Q-CPR meter 'Do not touch the patient" icon may incorrectly remain on the screen after shock delivery is complete.
Affected products
A. Heartstart MRX Defibrillator / Monitor
Lot or serial number
M3535A
M3536A
Model or catalog number
All lots
Companies
- Manufacturer
-
Philips Medical Systems
3000 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES
B. QCPR-CPR Meter Upgrade Kit
Lot or serial number
861444
Model or catalog number
All lots
Companies
- Manufacturer
-
Philips Medical Systems
3000 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES