BEUDAMED
    FDA Adverse Event Death Summary report: N

    OLL MEDICAL

    MDR report key: 72829 · Received February 28, 1997

    Report

    Report Number
    72829
    Event Type
    Death
    Date Received
    February 28, 1997
    Date of Event
    January 21, 1997
    Report Date
    February 28, 1997
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    LDD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT HAD UNEXPECTED CARDIO-PULMONARY ARREST. DEFIBRILLATOR FAILED TO DISCHARGE AT 250J AND AGAIN AT 300J, 1 MIN LATER FIRED ON 3RD ATTEMPT AND 4TH ATTEMPT BUT HAD ARC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLL MEDICAL DEFIBRILLATOR/MONITOR/PACER LDD ZOLL MEDICAL CORP. PD1200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Death