BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 540 CALIBRATOR

    MDR report key: 1761087 · Received July 14, 2010

    Report

    Report Number
    1828100-2010-00824
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    April 23, 2010
    Report Date
    July 14, 2010
    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

    DEVICE EVAL ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    DURING INCOMING INSPECTION OF THE DEVICE, OUR FOREIGN CONSIGNEE OBSERVED THAT THE GAS BOTTLE WAS EMPTY UPON CHECKING THE GAS LEVEL. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THE EVENT OCCURRED DURING INCOMING INSPECTION OF THE DEVICE, 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 GAS BOTTLE "B" DRY TERUMO CARDIOVASCULAR SYSTEMS CORP. CDI507 ZP12X029EA

    Patients

    Seq Age Sex Outcome Treatment
    1