BEUDAMED
    FDA Adverse Event Other Summary report: N

    HEWLETT-PACKARD/AGILENT TECHNOLOGIES

    MDR report key: 339727 · Received June 21, 2001

    Report

    Report Number
    339727
    Event Type
    Other
    Date Received
    June 21, 2001
    Date of Event
    May 4, 2001
    Report Date
    June 20, 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 WAS ADMITTED TO ICU FOR A CARDIOVERSION. AFTER THE CARDIOVERSION THE PT DEVELOPED "BURNS" ON HIS CHEST FROM THE CARDIOVERSION PADS. THE BURNS WERE COMPARABLE TO A SUNBURN. THE BIOMED TECHNICIAN WAS NOTIFIED AND ASKED TO CONTACT HEWLETT PACKARD IN REGARDS TO THE "BURNS" TO RULE OUT EQUIPMENT MALFUNCTION. HEWLETT-PACKARD VISITED THE HOSPITAL AND CHECKED THE EQUIPMENT AND FOUND NO PROBLEMS. HEWLETT-PACKARD DID REPLACE THE PADS CO HAD BEEN USING WITH NEW PADS. HEWLETT-PACKARD ALSO SAID THE PT MAY HAVE JUST HAD A REACTION TO THE GEL ON THE PADS. IN THE MEANTIME, FOLLOW-UP WAS DONE WITH AGILENT TECHNOLOGIES REGARDING CARDIOVERSION "BURNS". CO SENT ARTICLES PERTAINING TO THE "BURNS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28391 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