BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3932379 · Received April 1, 2014

    Report

    Report Number
    1218950-2014-01768
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Report Date
    March 4, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND CONFIRMED THE FAILURE. THE PROBLEM WAS TRACED TO THE CONNECTOR CABLE OF THE PADDLE SET. THE PADDLE CONNECTOR CABLE WAS ADJUSTED TO RESOLVE THE ISSUE. THE DEVICE CAUSED ALL PERFORMANCE ASSURANCE TESTS AND RETURNED TO USE. THIS WAS A MALFUNCTION OF THE PADDLE CONNECTOR CABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE WOULD NOT SHOCK. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196864 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1