BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 540 CALIBRATOR

    MDR report key: 1987061 · Received January 3, 2011

    Report

    Report Number
    1828100-2010-02819
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 15, 2010
    Report Date
    January 3, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A NON CLINICAL ACTIVITY, THE USER REPORTED THE CABLE OF THE CALIBRATOR WAS DAMAGED. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING A NON CLINICAL ACTIVITY, THERE WAS NO PT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO CDI 540 CALIBRATOR CALIBRATOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP 540

    Patients

    Seq Age Sex Outcome Treatment
    1