BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEARTSTART

    MDR report key: 554748 · Received October 29, 2004

    Report

    Report Number
    554748
    Event Type
    Other
    Date Received
    October 29, 2004
    Date of Event
    October 25, 2004
    Report Date
    October 29, 2004
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    THE NURSE TRIED TO ATTACH AN EXTERNAL MULTIFUCTION ELECTRODE PAD TO THE HEARTSTART DEFIBRILLATOR HANDS-FREE ELECTRODE CABLE. IT WOULD NOT ATTACH. THE NURSE FOUND THAT THE HEARTSTART DEFIBRILLATOR HANDS-FREE ELECTRODE CABLE END WAS BROKEN AND WOULD NOT ALIGN WITH THE CONNECTOR OF THE EXTERNAL MULTIFUNCTION ELECTRODE PAD. THE CABLE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART DEFIBRILLATOR MULTI-FUNCTION CABLE MLN PHILIPS MEDICAL SYSTEMS, INC. M3508A UNK
    2 HEARTSTART DEFIBRILLATOR/MONITOR MKJ PHILIPS MEDICAL SYSTEMS, INC. HEARTSTART XLT *

    Patients

    Seq Age Sex Outcome Treatment
    1 *