BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM XL

    MDR report key: 1061025 · Received June 12, 2008

    Report

    Report Number
    1218950-2008-00316
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Report Date
    May 15, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACTORY HAS NOT YET RECEIVED THE DEVICE FOR EVALUATION, AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WAS GETTING A PACER FAILURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1