BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3982586 · Received June 23, 2014

    Report

    Report Number
    1218950-2014-03410
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MJK
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PR#: (B)(4).

    Description of Event or Problem · 1

    DURING EVALUATION OF THE HEARTSTART MRX, THE PHILIPS BENCH REPAIR TECHNICIAN NOTED A TUCK PIN IN SLOT A OF THE BATTERY PCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367018 HEARTSTART MRX MJK PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1