BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM XL

    MDR report key: 1243007 · Received November 20, 2008

    Report

    Report Number
    1218950-2008-00638
    Event Type
    Malfunction
    Date Received
    November 20, 2008
    Report Date
    October 21, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE UNIT FAILED TO POWER UP. PHILLIPS EVALUATED THE UNIT AND CONFIRMED THE REPORTED FAILURE. THE MALFUNCTION WAS RESOLVED BY REPLACING THE POWER PCA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT FAILED TO POWER UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTREAM XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1