BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTIFUNCTION ADULT DEFIB ELECTRODE

    MDR report key: 210942 · Received February 19, 1999

    Report

    Report Number
    1218950-1999-00015
    Event Type
    Other
    Date Received
    February 19, 1999
    Date of Event
    January 22, 1999
    Report Date
    January 22, 1999
    Manufacturer
    KETECHO INC
    Product Code
    MLN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO HP THAT THE ICU STAFF ATTEMPTED TO EXTERNALLY PACE A PT WHO WAS EXPERIENCING A CARDIAC ARREST USING THE M3501A DEFIBRILLATOR PADS. THE ICU STAFF REPORTED THAT THEY COULD NOT ACHIEVE CAPTURE OF THE PT'S HEART ACTIVITY USING THE M3501A PADS. THEY SWITCHED TO A SET OF HP M1749A DEFIBRILLATOR PADS, ACHIEVED IMMEDIATE CAPTURE AND BEGAN TO PACE THE PT. UNFORTUNATELY, THE PT DIED. THE ICU STAFF HAS MADE NO ALLEGATION THAT THE M3501A PADS WERE THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIFUNCTION ADULT DEFIB ELECTRODE Implant MULTIFUNCTION ADULT DEFIB ELECTRODE MLN KETECHO INC M3501A K09-1898-3 2000-09

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death