BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL, BIPHASIC DEFIBRILLATOR

    MDR report key: 350061 · Received August 30, 2001

    Report

    Report Number
    350061
    Event Type
    Malfunction
    Date Received
    August 30, 2001
    Date of Event
    July 23, 2001
    Report Date
    August 6, 2001
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ATTEMPTING TO USE DEFIBRILLATOR ON PT AIRWAY IN FULL ARREST. MONITOR/DEFIBRILLATOR DID NOT DISCHARGE - READ DEFAULT ON SCREEN. PT HAD BEEN DEFIBRILLATED IN AMBULANCE, (SO DEFIBRILLATOR SET AT 200 JOULES ON ARRIVAL). ANOTHER DEFIBRILLATOR USED; WORKED PROPERLY. UNIT SENT TO BIOMED AND SENT TO MFR FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39632 ZOLL, BIPHASIC DEFIBRILLATOR BIPHASIC DEFIBRILLATOR MKJ ZOLL MEDICAL CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR