BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 1890129 · Received October 22, 2010

    Report

    Report Number
    1828100-2010-01845
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 10, 2010
    Report Date
    October 22, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    UPON RECEIPT OF THE DEVICE, THE USER REPORTED THE GAP TO HOLD THE COLOR RIBBON IN POSITION WAS TOO LARGE. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THIS EVENT WAS AN OUT OF BOX EVENT, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CDI 500 BLOOD PARAMETER MONITOR BLOOD PARAMETER PROBE DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. 145891

    Patients

    Seq Age Sex Outcome Treatment
    1