BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 540 CALIBRATOR

    MDR report key: 1842502 · Received August 31, 2010

    Report

    Report Number
    1828100-2010-01252
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 31, 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

    DEVICE EVAL ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    DURING ROUTINE TESTING OF THE DEVICE AT THE SVC CTR, THE SVC TECH REPORTED THE PRINTED CIRCUIT BOARD ASSEMBLY FAILED DURING THE CALIBRATION TEST FOR HIGH PRESSURE TRANSDUCER "A" SIDE. THE CALIBRATOR WAS ORIGINALLY RETURNED FOR "06" ERROR MESSAGE. SINCE THE EVENT OCCURRED DURING ROUTINE TESTING AT THE SVC CTR, 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