BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM XL

    MDR report key: 510764 · Received January 16, 2004

    Report

    Report Number
    1218950-2004-00022
    Event Type
    Malfunction
    Date Received
    January 16, 2004
    Report Date
    December 23, 2003
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THIS DEFIBRILLATOR WOULD NOT SHOW AN ECG WAVEFORM. THERE WAS NO REPORT OF 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