BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 540 CALIBRATOR

    MDR report key: 1881027 · Received October 8, 2010

    Report

    Report Number
    1828100-2010-01688
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 14, 2010
    Report Date
    October 8, 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

    EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE SERVICE TECHNICIAN REPORTED THE BOTTOM OF THE FRONT HOUSING OF THE CALIBRATOR WAS CRACKED, THIS CALIBRATOR WAS ORIGINALLY RETURNED FOR REPAIR DUE TO A CF0B ERROR CODE FAILURE WHEN THE CRACKED FRONT HOUSING WAS FOUND. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING 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 540 CALIBRATOR CALIBRATOR DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. 540

    Patients

    Seq Age Sex Outcome Treatment
    1