BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 540 CALIBRATOR

    MDR report key: 2182625 · Received July 5, 2011

    Report

    Report Number
    1828100-2011-01907
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 5, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE DEVICE WOULD NOT CALIBRATE. 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 540 CALIBRATOR CALIBRATOR DRY TERUMO CARDIOVASCULAR SYSTEM CORP 540

    Patients

    Seq Age Sex Outcome Treatment
    1