BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEWLETT-PACKARD/AGILENT TECHNOLOGIES

    MDR report key: 339730 · Received June 21, 2001

    Report

    Report Number
    339730
    Event Type
    Other
    Date Received
    June 21, 2001
    Date of Event
    May 5, 2001
    Report Date
    May 7, 2001
    Manufacturer
    AGILENT TECHNOLOGIES, INC.
    Product Code
    MLN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED "BURNS" FROM DEFIBRILLATOR PADS AFTER CARDIOVERSION. SAME TYPE OF INCIDENT OCCURRED THE DAY BEFORE. HEWLETT-PACKARD AND AGILENT TECH, INC WERE CONTACTED. A REP FROM HEWLETT-PACKARD VISITED THE HOSPITAL AND INSPECTED THE EQUIPMENT. REPLACED THE OLD PADS WITH NEW PADS BUT FELT THERE WAS NO MEDICAL EQUIPMENT MALFUNCTION. THEY FELT PTS WERE JUST HAVING A SKIN REACTION. AGILENT TECHNOLOGIES SENT SOME LITERATURE REGARDING THE "BURNS". ALL OF THIS INFO HAS BEEN REVIEWED WITH THE STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28394 HEWLETT-PACKARD/AGILENT TECHNOLOGIES M3501A MULTIFUNCTION ADULT DEFIB ELECTRODES MLN AGILENT TECHNOLOGIES, INC. M3501-A K030101-3

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other