BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2472714 · Received February 23, 2012

    Report

    Report Number
    1218950-2012-00621
    Event Type
    Malfunction
    Date Received
    February 23, 2012
    Report Date
    January 30, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS-DUP
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTS THAT THE DEVICE HAS A DISPLAY THAT GOES BLANK INTERMITTENTLY. THERE WAS NO REPORTED PT INVOLVEMENT. PHILIPS REPAIR BENCH EVALUATED THE DEVICE AND COULD NOT DUPLICATE THE REPORTED COMPLAINT. ALL PERFORMANCE ASSURANCE TESTS PASSED, AND THE DEVICE WAS SENT BACK TO THE CUSTOMER. AS OF (B)(4) 2012 THERE HAVE BEEN NO FURTHER CALLS FOR THIS DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE DEVICE HAS A DISPLAY THAT GOES BLANK INTERMITTENTLY. 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