BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART 4000

    MDR report key: 378779 · Received February 21, 2002

    Report

    Report Number
    1218950-2002-00026
    Event Type
    Malfunction
    Date Received
    February 21, 2002
    Report Date
    January 22, 2002
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS MEDICAL SYSTEMS THAT AN ECG FAULT ERROR WAS DISPLAYED WHEN TURNING THE DEFIBRILLATOR ON.

    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