BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1873448 · Received October 14, 2010

    Report

    Report Number
    1218950-2010-01952
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Report Date
    August 12, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHILIPS WAS NOTIFIED THAT THE UNIT FAILED TO POWER UP. THE UNIT WAS REPAIRED LOCALLY BY REPLACING THE OPTICAL SWITCH. REPLACING THE OPTICAL SWITCH RESOLVED THE REPORTED FAILURE.

    Description of Event or Problem · 1

    PHILIPS WAS NOTIFIED THAT THE UNIT FAILED 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