—#91334

Product

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.

FDA product code: MKJ — Automated External Defibrillators (Non-Wearable)
Device class: Class 3
Medical specialty: Cardiovascular
510(k) numbers: K051134
Affected lot / code info: 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.

Why it was recalled

Reduced sensitivity in the force measurement sensor can result in inaccurate feedback to the user on how well he or she is releasing pressure after each chest compression. This can result in incomplete release of chest compression, which will reduce CPR effectiveness.

Root cause (FDA determination)

Device Design

Action the firm took

Philips issued an "Urgent Medical Device Recall notification/Field Safety Notice" dated April 2010 to all consignees. The letter described the issue, how to identify affected devices, and required actions. The consignees were instructed to remove affected devices from service. Philips will contact consignees to arrange on-site replacement of affected meters with meters containing revised labeling and calibration software. The new meters will indicate that meter recalibration is required after approximately 50,000 compression cycles. Consignees returning devices to Philips for routine recalibration will receive free replacement. All CPR meters will be replaced with re-designed meters when they become available. For questions or assistance in notifying accounts about this recall, contact Philips at 1-800-722-9377.

Recalling firm

Firm: Philips Healthcare Inc.
Address: 3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-05-06
Posted by FDA: 2010-08-27
Terminated: 2013-02-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91334. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.