Devices

Device Recall HeartStart MRx Defibrillator/Monitor with QCPRTM

Model / Serial
M3535A/M3536A HeartStart MRx 453564145481 MRx Q-CPR meter 861444, MRx Q-CPR Meter Upgrade 989803162401, MRx Replacement Q-CPR Meter. Lot numbers on distribution list.
Product Classification
Cardiovascular Devices
Device Class
3
Implanted device?
No
Distribution
Worldwide distribution in the countries of USA, Canada, Australia, China, Germany, Iceland, India, Libyan Arab Jamahiri, Netherlands, Saudi Arabia, Spain, Switzerland, United Arab Emirates, and United Kingdom.
Product Description
HeartStart MRx Defibrillator/Monitor with Q-CPR || Meter option.The HeartStart MRx monitor/defibrillator has an option (Q-CPR Meter) to provide visual and audible feedback to the rescuer on the quality of CPR. The Q-CPR option offers real time measurement and corrective feedback on the rate, depth and complete release of compressions, ventilations rate and lack of CPR activity in accordance with current CPR guidelines. The Q-CPR option is contraindicated as follows: *The Q-CPR option is contraindicated for use on neonatal and pediatric patients (under 8 years of age or weighing less than 25 kg). *The Q-CPR option is not for use when CPR is contraindicated.
Manufacturer
Philips Healthcare Inc.
1 Event
- Recall of Device Recall HeartStart MRx Defibrillator/Monitor with QCPRTM

Manufacturer

Philips Healthcare Inc.

Manufacturer Address
Philips Healthcare Inc., 3000 Minuteman Road, Andover MA 01810
Manufacturer Parent Company (2017)
Philips
Source
USFDA

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