BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL MEDICAL CORPORATION

    MDR report key: 2209525 · Received August 8, 2011

    Report

    Report Number
    MW5021693
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    June 30, 2011
    Report Date
    August 8, 2011
    Manufacturer
    ZOLL MEDICAL CORP.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ON SCENE, PARAMEDICS INTERPRETED PATIENT RHYTHM ON ZOLL MONITOR SCREEN AS ASYSTOLE. POST INCIDENT REVIEW OF CODE INFORMATION REVEALED A DIFFERENT RHYTHM TRACING THAN HAD BEEN SEEN ON THE MONITOR SCREEN. WHEN 2 PATIENT WAVEFORMS AND THE "DASHBOARD" ARE USED TOGETHER ON THE MONITOR SCREEN, THE ECG WAVEFORM IS EFFECTIVELY REDUCED BY ONE-HALF, RESULTING IN A SMALLER, NOT READILY DISCERNIBLE WAVEFORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL MEDICAL CORPORATION ZOLL E-SERIES MONITOR/DEFIBRILLATOR MKJ ZOLL MEDICAL CORP. E-SERIES

    Patients

    Seq Age Sex Outcome Treatment
    1