FDA MedWatch - HeartStart MRx Monitor/Defibrillator by Phillips Healthcare: Class I Recall - Electrical Issues

["FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - HeartStart MRx Monitor/Defibrillator by Phillips Healthcare: Class I Recall - Electrical Issues

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

HeartStart MRx Monitor/Defibrillator by Phillips Healthcare: Class I Recall - Electrical Issues

AUDIENCE: Risk Manager, Emergency Medicine

ISSUE: Phillips is recalling the HeartStart MRx Monitor/Defibrillator due to electrical and battery connection issues that may prevent the device from powering up, charging, and delivering an 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.

• Manufacturing dates: February 11, 2004 to November 4, 2016
• Distribution dates: February 12, 2004 to November 4, 2016

See the FDA Recall Notice for a list of affected model numbers.

BACKGROUND: 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. The HeartStart MRx Monitor/Defibrillator is intended for use by medical professionals who are trained in CPR.

RECOMMENDATION: In February 2017, Phillips Healthcare sent an “Urgent Medical Device Correction” notice to its customers. 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.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the recall notice, at:

https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm548559.htm

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You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

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