BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 540 CALIBRATOR

    MDR report key: 1881797 · Received October 8, 2010

    Report

    Report Number
    1828100-2010-01678
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 13, 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 HOOK KNOB WAS MISSING FROM THE CALIBRATOR. THIS CALIBRATOR WAS ORIGINALLY RETURNED FOR REPAIR OF A GAS READING ERROR WHEN THE HOOK KNOB WAS FOUND TO BE MISSING. SINCE THE EVENT OCCURRED AT THE SERVICE CENTER, THERE WAS NO PATIENT 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