BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZOLL MEDICAL CORP.

    MDR report key: 522953 · Received April 21, 2004

    Report

    Report Number
    522953
    Event Type
    Death
    Date Received
    April 21, 2004
    Date of Event
    September 1, 2003
    Report Date
    December 1, 2003
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT REQUIRED PACING. DEFIBRILLATOR/PACER HAD FAILED EARLIER ROUTINE TEST BUT HAD NOT BEEN REPORTED. A SPARE DEFIBRILLATOR WITH PACING WAS NOT IMMEDIATELY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL MEDICAL CORP. DEFIBRILLATOR/MONITOR/PACER MKJ ZOLL MEDICAL CORPORATION PD-1200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death