BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL MEDICAL CORPORATION

    MDR report key: 77847 · Received March 14, 1997

    Report

    Report Number
    77847
    Event Type
    Malfunction
    Date Received
    March 14, 1997
    Date of Event
    January 30, 1997
    Report Date
    February 12, 1997
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEFIBRILLATOR CORD DID NOT DELIVER ENERGY FOR INTERNAL DEFIBRILLATION. TRIED FOUR TIMES. CORD CHANGED AND PT CONVERTED FROM VENTRICULAR FIBRILLATION TO REGULAR SINUS RHYTHM. EVENT OCCURRED IN SURGERY; PREPARING PT TO BE TAKEN OFF BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL MEDICAL CORPORATION DEFIBRILLATOR CORD LDD ZOLL MEDICAL CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR