BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL MEDICAL CORP

    MDR report key: 271153 · Received March 23, 2000

    Report

    Report Number
    271153
    Event Type
    Injury
    Date Received
    March 23, 2000
    Date of Event
    March 10, 2000
    Report Date
    March 21, 2000
    Manufacturer
    ZOLL MEDICAL CORP
    Product Code
    MLN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING RESUSCITATION OF ABOVE PT, DEFIBRILLATION WAS DEEMED NECESSARY. THE ZOLL PACER/DEFIB PADS WERE PLACED AS RECOMMENDED, AND THE DEFIBRILLATOR WAS CHARGED TO 200 JOULES. THE DISCHARGE BUTTON WAS PUSHED, AND THE DEFIBRILLATOR DID NOT DISCHARGE. IT WAS IMMEDIATELY RECHARGED TO 200. AT THE DISCHARGE A YELLOW/ORANGE SPARK APPROX 2-3 INCHES IN LENGTH WAS SEEN BY THE STAFF. THE SPARK EMITTED FROM THE CHEST PAD AND APPARENTLY HIT THE RESERVOIR BAG OF THE AMBU BAG, WHICH BROKE OUT INTO FLAMES. THE FIRE WAS PROMPTLY EXTINGUISHED. THE PT APPEARED TO HAVE MINOR BURNS ON CHEST AND LEFT HAND. THE PT WAS PULSELESS, WITHOUT RESPIRATORY EFFORT OR BLOOD PRESSURE PRIOR TO THE INCIDENT. RESUSCITATION ATTEMPTS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL MEDICAL CORP DEFIBRILLATOR MLN ZOLL MEDICAL CORP PD-1200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening