BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 4232365 · Received August 15, 2014

    Report

    Report Number
    1218950-2014-04926
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Report Date
    June 27, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    WHILE THE DEVICE WAS AT THE PHILIPS CUSTOMER REPAIR CENTER (CRC) FOR A DIFFERENT ISSUE, THE BENCH TECHNICIAN FOUND THAT THE DEVICE WOULD NOT CHARGE TO FULL CAPACITY AT ANY ENERGY SETTING DURING PERFORMANCE VERIFICATION TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490118 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1