BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL MEDICAL CORPORATION

    MDR report key: 2948871 · Received January 31, 2013

    Report

    Report Number
    MW5028849
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 31, 2013
    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

    ONGOING APPROX ONE YR NIBP ISSUES WITH ZOLL E-SERIES MONITOR/DEFIBRILLATORS. WE'VE EXPERIENCED REPEATED LOW B/P READINGS ON PTS DURING TRANSPORT FROM SCENE TO HOSPITAL THAT RESULTED IN CLINICAL TREATMENT DECISIONS THAT WERE NOT APPROPRIATE FOR THE PT. IN THE MOST RECENT EVENT, THE PT HAD A STRONG PULSE AT THE SCENE, B/P ON SCENE WAS SATISFACTORY, DURING TRANSPORT TO HOSPITAL MONITOR READ LOW B/P FOR PT AND, UPON ARRIVAL AT THE HOSPITAL, PT B/P WAS SATISFACTORY AGAIN. PARAMEDICS USED A BACK-UP DEVICE TO VERIFY B/P AND FOUND IT TO BE WITHIN A SATISFACTORY RANGE. FROM OUR PERSPECTIVE, THE MOTION ARTIFACT SENSOR ON THE E-SERIES UNIT IS ENTIRELY TOO SENSITIVE TO VEHICLE MOTION AND THIS INTERFERES WITH PROPER B/P MEASUREMENTS. THIS PROBLEM HAS BEEN IDENTIFIED AND ASSOCIATED WITH SEVERAL AMBULANCE CALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42293 ZOLL MEDICAL CORPORATION ZOLL E-SERIES MONITOR/DEFIBRILLATOR MKJ ZOLL MEDICAL CORP. 50001730020124013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other