BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART 4000

    MDR report key: 380130 · Received February 22, 2002

    Report

    Report Number
    1218950-2002-00027
    Event Type
    Other
    Date Received
    February 22, 2002
    Report Date
    January 25, 2002
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING TESTING, AFTER THE UNIT DELIVERED APPROXIMATELY FORTY 150J SHOCKS CONSECUTIVELY, THE DEFIBRILLATOR GAVE AN ERROR CODE "SYSTEM ERROR 10001".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART 4000 DEFIBRILLATOR/MONITOR MKJ AGILENT TECHNOLOGIES, INC. M5500B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA