BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2974520 · Received January 28, 2013

    Report

    Report Number
    1218950-2013-00279
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 2, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PHILIPS BENCH TECHNICIAN EVALUATED THE DEVICE AND VERIFIED THE FAILURE. THE ISSUE WAS DIAGNOSED AS AN AC POWER SUPPLY FAILURE. THE AC POWER SUPPLY WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE PASSED ALL TESTING AND WAS SHIPPED BACK TO THE CUSTOMER SITE. WE ARE CONSIDERING THIS A MALFUNCTION RESULTING FROM A FAILURE OF THE AC POWER SUPPLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE AC POWER AND BATTERY CHARGE LEDS WERE FAILING, THE DEVICE WAS NOT CHARGING THE BATTERY PROPERLY. THESE SYMPTOMS ARE INDICATIVE OF THE DEVICE ALSO FAILING TO POWER UP VIA AC POWER. NO PT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38372 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1