BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM XL

    MDR report key: 536474 · Received March 22, 2004

    Report

    Report Number
    1218950-2004-00071
    Event Type
    Malfunction
    Date Received
    March 22, 2004
    Report Date
    February 23, 2004
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEFIBRILLATOR WOULD NOT POWER UP ON INITAL INTAKE EVALUATION. THERE WAS NO PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA