BEUDAMED
    FDA Adverse Event Injury Summary report: N

    D2000 ADVISORY

    MDR report key: 57968 · Received December 20, 1996

    Report

    Report Number
    1220908-1996-00126
    Event Type
    Injury
    Date Received
    December 20, 1996
    Report Date
    December 19, 1996
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    STAFF MEMBERS WERE TREATING A 40 YR OLD FEMALE PT WHO REQUIRED DEFIBRILLATION. THE STAFF ATTACHED THE UNIT TO THE PT USING A MULTI-FUNCTION CABLE (MFC) AND MULTI-FUNCTION ELECTRODES (MFE). THE STAFF CHARGED THE UNIT TO THE TARGET ENERGY, BUT IT DID NOT DISCHARGE. THE STAFF INDICATED THAT THE PT DID NOT "JUMP". THE STAFF OBTAINED A PD120 MFC AND ATTACHED IT TO THE ORIGINAL MFE. THE STAFF DEFIBRILLATED THE PT AND INDICATED THAT THE PT DID "JUMP A BIT". THE PT LATER EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 D2000 ADVISORY DEFIBRILLATOR MKJ ZOLL MEDICAL CORP. D2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death