BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2533036 · Received April 3, 2012

    Report

    Report Number
    1218950-2012-01142
    Event Type
    Malfunction
    Date Received
    April 3, 2012
    Report Date
    March 12, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS-DUP
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED V6 WAS MISSING. THE CUSTOMER CONFIRMED THAT THE CAUSE WAS A BAD TRUNK CABLE AND THE CUSTOMER SCRAPPED IT. A PHILIPS REPAIR TECHNICIAN EVALUATED THE DEVICE. THE TECHNICIAN RAN ALL THE PERFORMANCE ASSURANCE TESTS PASSED AND THE DEVICE WAS SENT BACK TO THE CUSTOMER FOR USE. AS OF 03/03/2012, THERE HAS BEEN NO FURTHER CALLS FOR THIS DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED V6 WAS MISSING.

    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