BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 3060117 · Received March 20, 2013

    Report

    Report Number
    1218950-2013-00957
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Report Date
    February 25, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE HAD A DISTORTED DISPLAY. THERE WAS NO REPORTED PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY A PHILIPS REPAIR TECHNICIAN AND CONFIRMED. THE PROBLEM WAS TRACED TO A FAULTY DISPLAY ASSEMBLY. IT WAS REPORTED THE DISPLAY IS DISTORTED. THIS CAN IMPACT THE DELIVERY OF THERAPY. THE BENCHED REPLACED THE DISPLAY ASSEMBLY TO RESOLVE THE PROBLEM. ALL PERFORMANCE ASSURANCE TESTS PASSED AND THE DEVICE WAS SENT BACK TO THE CUSTOMER. THIS WAS A MALFUNCTION OF THE DISPLAY ASSEMBLY THAT CAUSED THE DEVICE TO HAVE A DISTORTED DISPLAY. NO FORMAL RESPONSE WAS REQUESTED AND NONE IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE HAD A DISTORTED DISPLAY. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115079 HEARTSTART MRX -EMS DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1