BEUDAMED
    FDA Adverse Event Summary report: N

    HEARTSTREAM XL

    MDR report key: 1213815 · Received October 22, 2008

    Report

    Report Number
    1218950-2008-00568
    Date Received
    October 22, 2008
    Report Date
    September 22, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE UNIT FAILED TO RECOGNIZE THAT PADS OR PADDLES WERE ATTACHED DURING THE SHIFT / SYSTEM TEST. THE FACTORY HAS NOT YET RECEIVED THE DEVICE FOR EVALUATION, AND THE COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED, UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT FAILED TO RECOGNIZE THAT PADS OR PADDLES WERE ATTACHED DURING THE SHIFT / SYSTEM TEST.

    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