BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 3100001 · Received April 26, 2013

    Report

    Report Number
    1218950-2013-01485
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 2, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PHILIPS BENCH TECHNICIAN NOTED THAT THE DEVICE WAS NOT DETECTING THE THERAPY CABLE AND TEST LOAD. THE CAUSE OF THE ISSUE WAS LOCALIZED TO A FAILURE OF THE POWER PCA. THE POWER PCA WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL TESTING AND WAS PLACED BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT UPON POWER UP THERE WAS A MESSAGE "DEVICE ERR SERVICE REQ" AND AFTER OPERATIONAL CHECK THERE WAS AN ERROR CODE "OPS CHECK FAILED SERVICE DEVICE". THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181974 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1