BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3003564 · Received February 11, 2013

    Report

    Report Number
    1218950-2013-00490
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    January 16, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYED ERROR CODE 0100. AFTER DISPLAYING ERROR CODE 01000 (DEFIB BIPHASE ERROR) THE MESSAGE/INSTRUCTION DEFIB FAILURE CYCLE POWER IS DISPLAYED AND DEVICE OPERATION IS HALTED. THIS ISSUE WAS FOUND DURING USER INITIATED TESTING. THERE WAS NO PATIENT INVOLVEMENT. THE LOCAL PHILIPS AUTHORIZED SERVICE REP EVALUATED THE DEVICE AND THE STATED PROBLEM WAS CONFIRMED. THE POWER PCA WAS REPLACED TO RESOLVE THE MALFUNCTION. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYED ERROR CODE 0100. AFTER DISPLAYING ERROR CODE 01000 (DEFIB BIPHASE ERROR) THE MESSAGE/INSTRUCTION DEFIB FAILURE CYCLE POWER IS DISPLAYED AND DEVICE OPERATION IS HALTED. THIS ISSUE WAS FOUND DURING USER INITIATED TESTING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60139 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1