BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD GLUCOSE PARAMETER MONITOR

    MDR report key: 2210300 · Received August 8, 2011

    Report

    Report Number
    1828100-2011-02368
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 15, 2011
    Report Date
    August 8, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A SURGICAL PROCEDURE, THE USER REPORTED THAT THE MONITOR SCREEN WAS BLANK, RED, AND FUZZY. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CDI 500 BLOOD GLUCOSE PARAMETER MONITOR ON LINE BLOOD GLUCOSE GAS MONITOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP 500AVHCT

    Patients

    Seq Age Sex Outcome Treatment
    1