BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 3043374 · Received March 11, 2013

    Report

    Report Number
    1218950-2013-00855
    Event Type
    Malfunction
    Date Received
    March 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT STOP BEEPING. THERE WAS NO REPORTED PATIENT INVOLVEMENT. A PHILIPS BENCH TECHNICIAN EVALUATED THE DEVICE. POWER ERRORS WERE FOUND IN THE DEVICE ERROR LOG THAT POINT TO A FAULTY BATTERY. THE CUSTOMER WAS CONTACTED AND TOLD ABOUT THE BATTERY ISSUE. THE SPECIFIC BATTERY INVOLVED IN THE DEVICE COULD NOT BE ISOLATED FROM THE OTHER BATTERIES THE CUSTOMER HAD. THE CUSTOMER WAS TOLD TO KEEP BATTERIES WITH THE DEVICE IF THERE WAS ANOTHER PROBLEM. THE CUSTOMER WAS INFORMED OF THE FAULTY BATTERY. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS RETURNED TO THE CUSTOMER. THIS WAS A MALFUNCTION THAT CAUSED POWER SUPPLY ERRORS. THE CAUSE COULD NOT BE VERIFIED BECAUSE THE SUSPECTED FAULTY BATTERY WAS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT STOP BEEPING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102727 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1