BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM XL

    MDR report key: 385119 · Received March 25, 2002

    Report

    Report Number
    1218950-2002-00047
    Event Type
    Malfunction
    Date Received
    March 25, 2002
    Report Date
    February 21, 2002
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT UPON RECEIPT OF THE DEFIBRILLATOR, ERROR CODE "SYSTEM FAILURE-CYCLE POWER ERROR 20004" APPEARED AT POWER ON.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA