BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 540 CALIBRATOR

    MDR report key: 2181038 · Received July 1, 2011

    Report

    Report Number
    1828100-2011-01815
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    May 24, 2011
    Report Date
    July 1, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DRY
    PMA / PMN Number
    K972962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE USER REPORTED THAT A "SYSTEM LEAK TEST" FAILURE OCCURRED. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING, 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