BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM XL

    MDR report key: 1250839 · Received November 25, 2008

    Report

    Report Number
    1218950-2008-00657
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Report Date
    October 28, 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. THE UNIT WAS EVALUATED AT PHILIPS, AND THE REPORTED FAILURE WAS VERIFIED. REPLACEMENT OF THE POWER PCA RESOLVED THIS FAILURE.

    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