BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOLIFE

    MDR report key: 18850 · Received November 23, 1994

    Report

    Report Number
    18850
    Event Type
    Injury
    Date Received
    November 23, 1994
    Date of Event
    November 15, 1994
    Report Date
    November 17, 1994
    Manufacturer
    NIHON KOHDEN (AMERICA), INC.
    Product Code
    LDD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING DEFIBRILLATION OF PT, WHO WAS EXPERIENCING VENTRICULAR FIBRILLATION, THE DEFIBRILLATOR PADDLES ARCED AND WHEN THE PADDLES WERE LIFTED OFF THE PT'S CHEST, THE ADULT PADDLES FELL OFF THE HANDSET. DELAYED DEFIBRILLATION OF PT ENSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOLIFE DEFIBRILLATOR LDD NIHON KOHDEN (AMERICA), INC. TEC-7100-A

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening