BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZOLL

    MDR report key: 1842613 · Received September 24, 2010

    Report

    Report Number
    MW5017500
    Event Type
    Injury
    Date Received
    September 24, 2010
    Date of Event
    September 12, 2010
    Report Date
    September 24, 2010
    Manufacturer
    ZOLL
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED TO ER ON 09/10, TRANSFERRED TO MEDICAL FLOOR AND ON 09/11 WAS TRANSFERRED TO PROGRESSIVE CARE UNIT -PCU- FOR MONITORING. THE PT DEVELOPED CARDIAC ARRHYTHMIAS AND SUBSEQUENTLY A CODE BLUE WAS INITIATED. DURING THE RESUSCITATION THE PT WAS ELECTRONICALLY DEFIBRILLATED TWO TIMES. ON THE THIRD ATTEMPT, THE DEFIBRILLATOR DID NOT FIRE. ANOTHER DEFIBRILLATOR UNIT FROM WITHIN THE AREA WAS OBTAINED AND THE CODE CONTINUED. THE PT'S CONDITION WAS NOT COMPROMISED DURING THIS PERIOD. THE PT DID NOT SURVIVE, HOWEVER, THE CAUSE OF DEATH WAS NOT RELATED TO THE MALFUNCTION OF THE DEFIBRILLATOR. THE UNIT THAT MALFUNCTIONED WAS REMOVED FROM SERVICE AND SENT TO THE BIO-MED DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL DEFIBRILLATOR MKJ ZOLL M-SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening