BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2121222 · Received May 4, 2011

    Report

    Report Number
    1218950-2011-01285
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Report Date
    April 8, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE UNIT FAILED THE OPCHECK WITH A "FAIL/DX." THE CUSTOMER ALSO REPORTED THAT THE UNIT IS NOT RECOGNIZING A NON-PHILIPS BATTERY IN THE B BATTERY COMPARTMENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. THE UNIT WAS EVALUATED AT PHILIPS. THE REPORTED ISSUE WITH THE NON-PHILIPS BATTERY COULD NOT BE CONFIRMED AS THE BATTERY WAS NOT SENT IN WITH THE UNIT. UPON EVALUATION, THIS UNIT HAD A CRITICAL CHARGE SHOCK FAILURE. REPLACEMENT OF THE THERAPY PCA RESOLVED THE FAILURE. THE UNIT PASSED ALL POST-SERVICING TESTING AND WAS SENT BACK TO THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT FAILED THE OPCHECK WITH A "FAIL/DX." THE CUSTOMER ALSO REPORTED THAT THE UNIT IS NOT RECOGNIZING A NON-PHILIPS BATTERY IN THE B BATTERY COMPARTMENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1