March 28, 2017 — Philips and the U.S. Food and Drug Administration (FDA) announced the company has initiated a recall of its HeartStart MRx Monitor/Defibrillator. The Class I recall is due to electrical and battery connection issues that may prevent the device from powering up, charging and delivering electrical shock therapy. The device may also unexpectedly stop pacing. A delay in delivering therapy could result in serious patient injury such as permanent organ damage, brain injury or death.
The HeartStart MRx Monitor/Defibrillator is used to pace people with a slow heart beat or to deliver lifesaving electrical shocks to people with sudden cardiac arrest. Electrodes are attached to the patient and then connected to the device to help it analyze a patient's heart rhythm. The electrodes deliver an electrical shock to restore a normal heart rhythm during sudden cardiac arrest, or to pace the heart at a normal rate when it slows down. The HeartStart MRx Monitor/Defibrillator is intended for use by medical professionals who are trained in CPR.
Philips sent an “Urgent Medical Device Correction” notice to its customers in February. The company said the cause of the issue can be easily verified by:
- Identifying affected devices in their possession using the model number information;
- Inspecting that the battery connector pins are clean, fully extended, and free of residue;
- Following the rest of the instructions enclosed in the notice, including:
- Reviewing the information with other staff trained in the use of the defibrillator;
- Filling out and return the ‘Confirmation Response’ included with the notice; and
- Contacting Phillips Healthcare for further information or support at 1-800-722-9377.
Affected model numbers include M3535A (M3535ATZ) M3536A (M3536ATZ), M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8 and M3536M9. The recall impacts devices manufactured between Feb. 11, 2004 and Nov. 4, 2016; and devices distributed between Feb. 12, 2004 and Nov. 4, 2016.
Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Reporting Program either online, by regular mail or by fax to 1-800-FDA-0178.
For more information: www.fda.gov/medicaldevices/safety