BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX ¿ EMS DEFIBRILLATOR

    MDR report key: 2501733 · Received February 27, 2012

    Report

    Report Number
    1218950-2012-00657
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Report Date
    January 31, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS-DUP
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTS THAT THE DEVICE FAILS TO CHARGE DURING OPERATIONAL CHECK. THERE WAS NO REPORTED PT INVOLVEMENT. PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND CONFIRMED THE PROBLEM. IT WAS FOUND THAT THE DEVICE NEEDED TO HAVE THE MAIN BOARD REPLACED (PROCESSOR PCA). ALL PERFORMANCE ASSURANCE TESTS PASSED AND THE DEVICE WAS PUT BACK INTO SERVICE. WE WILL CONSIDER THIS A MALFUNCTION OF THE PROCESSOR PCA THAT CAUSED THE DEVICE TO FAIL TO CHARGE DURING OPERATIONAL CHECK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE DEVICE FAILS TO CHARGE DURING OP CHECK. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1