BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 2152968 · Received June 17, 2011

    Report

    Report Number
    1828100-2011-01704
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 17, 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
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE SPRING CLIP WAS BROKEN ON THE HEMATOCRIT SATURATION PROBE. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO A PT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1