BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3090133 · Received April 19, 2013

    Report

    Report Number
    1218950-2013-01433
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Report Date
    March 31, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE. THE ISSUE WAS DETERMINED TO BE A FAULTY AC POWER SUPPLY. THE AC POWER SUPPLY WAS REPLACED WHICH RESOLVED THE ISSUE. THE DEVICE PASSED ALL TESTING AND REMAINS AT THE CUSTOMER SITE. THIS WAS A MALFUNCTION OF THE AC POWER SUPPLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE AC POWER LED WAS NOT BRIGHT. THERE WAS NO PT INVOLVEMENT AS THIS WAS DISCOVERED IN TESTING. A PHILIPS FIELD SERVICE ENGINEER CLARIFIED THAT THE DEVICE CANNOT BOOT UP ON AC POWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169503 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1