BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3063451 · Received March 28, 2013

    Report

    Report Number
    1218950-2013-01140
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    October 4, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE LEAKAGE TEST FAILED FOR THIS DEVICE. THE DEVICE WAS EVALUATED LOCALLY. THE REPORTED SYMPTOM WAS CONFIRMED. THE POWER SUPPLY WAS REPLACED TO RESOLVE THE SYMPTOM. AFTER PASSING ALL TESTING THE DEVICE WAS RETURNED TO USE. THIS COMPLAINT REPRESENTS A POWER SUPPLY FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LEAKAGE TEST FAILED FOR THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127261 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1