BEUDAMED
    FDA Adverse Event Other Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 1744655 · Received June 30, 2010

    Report

    Report Number
    1828100-2010-00752
    Event Type
    Other
    Date Received
    June 30, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 30, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING ROUTINE TESTING OF THE DEVICE AT THE DEVICE AT THE SERVICE CENTER, THE REPAIR TECHNICIAN REPORTED THAT THE BLOOD PARAMETER MONITOR PROBE FAILED THE MANUFACTURING SELF-TEST. THE MONITOR WAS ORIGINALLY RETURNED FOR A FAILURE TO CALIBRATE WHEN THE TECHNICIAN OBSERVED THE PROBE FAILURE. SINCE THIS EVENT OCCURRED AT THE SERVICE CENTER, 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 MODULE DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. 145891

    Patients

    Seq Age Sex Outcome Treatment
    1