BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTREAM XL

    MDR report key: 313760 · Received January 22, 2001

    Report

    Report Number
    1218950-2001-00030
    Event Type
    Other
    Date Received
    January 22, 2001
    Report Date
    December 21, 2000
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEFIBRILLATOR FAILED WHEN POWERED ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2696 HEARTSTREAM XL DEFIBRILLATOR MKJ AGILENT TECHNOLOGIES, INC. M4735A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA