BEUDAMED
    FDA Adverse Event Other Summary report: N

    TERUMO CDI 500 BLOOD PARAMETER MONITOR

    MDR report key: 1914416 · Received November 16, 2010

    Report

    Report Number
    1828100-2010-02141
    Event Type
    Other
    Date Received
    November 16, 2010
    Date of Event
    October 21, 2010
    Report Date
    November 16, 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

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    UPON RECEIPT OF THE DEVICE, OUR FOREIGN CONSIGNEE REPORTED THE BLOOD PARAMETER PROBE HAD AN ELECTRONIC ERASABLE PROGRAMMABLE READ ONLY MEMORY FAILURE IN THE TEST SOFTWARE. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED UPON RECEIPT OF THE DEVICE, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1