BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM XL

    MDR report key: 1071821 · Received July 8, 2008

    Report

    Report Number
    1218950-2008-00384
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Report Date
    June 11, 2008
    Manufacturer
    AGILENT TECHNOLOGIES INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACTORY HAS NOT YET REC'D THE DEVICE FOR EVAL, AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTREAM XL DEFIBRILLATOR MKJ AGILENT TECHNOLOGIES INC. M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1