BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3090199 · Received April 19, 2013

    Report

    Report Number
    1218950-2013-01421
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Report Date
    March 25, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A PHILIPS BENCH TECHNICIAN EVALUATED THE DEVICE AND CONFIRMED THE FAILURE. THE DEVICE WAS FOUND TO POWER UP WITH A CYCLE POWER ERROR 10001 AND WAS NOT ABLE TO FULLY BOOT UP. THE PROBLEM WAS TRACED TO A FAULTY CONTROL PCA. THE CONTROL PCA WAS REPLACED TO RESOLVE THE FAILURE. THE DEVICE PASSED ALL PERFORMANCE ASSURANCE TESTS AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE POWERED UP WITH A BEEPING TONE AND THE SCREEN FLASHED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169710 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1