BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2980972 · Received February 4, 2013

    Report

    Report Number
    1218950-2013-00379
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    January 8, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO DETECT THE TEST LOAD AND DISPLAYED AN ERROR MESSAGE. THERE WAS NO REPORTED PT INVOLVEMENT. PHILIPS BENCH TECH EVALUATED THE DEVICE AND CONFIRMED THE FAILURE. A FAULTY POWER PCA WAS FOUND TO BE THE CAUSE OF THE FAILURE. THE POWER PCA WAS REPLACED TO RESOLVE THE FAILURE. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS RETURNED TO THE CUSTOMER. THIS WAS A MALFUNCTION OF THE POWER PCA THAT CAUSED THE PADS/PADDLES ECG FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO DETECT THE TEST LOAD AND DISPLAYED AN ERROR MESSAGE. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45979 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1