BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL

    MDR report key: 1854515 · Received September 30, 2010

    Report

    Report Number
    1218950-2010-01773
    Event Type
    Malfunction
    Date Received
    September 30, 2010
    Report Date
    August 5, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FACTORY HAS NOT YET REC'D THE DEVICE FOR EVALUATION AND THIS COMPLAINT REMAINS UNDER INVESTIGATION. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT SHOWED THE SCREEN MESSAGE "SERVICE REQUIRED."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1