BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1882444 · Received October 20, 2010

    Report

    Report Number
    1218950-2010-01988
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    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), THE CUSTOMER REPORTED THAT THE SCREEN WAS NOT DISPLAYING AS A RESULT OF A FAILURE TO POWER UP. THE DEVICE WAS EVALUATED LOCALLY. REPLACING THE OPTICAL/THERAPY SWITCH RESOLVED THE FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SCREEN WAS NOT DISPLAYING AS A RESULT OF A FAILURE TO POWER UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ PHILIPS HEALTHCARE M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1