BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 101 MONITOR

    MDR report key: 1940189 · Received December 23, 2010

    Report

    Report Number
    1828100-2010-02755
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    September 16, 2010
    Report Date
    December 23, 2010
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTY
    PMA / PMN Number
    K902654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 TECH REPORTED THE OMNI BOARD FAILED. SINCE THIS 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 101 MONITOR MONITOR DTY TERUMO CARDIOVASCULAR SYSTEMS CORP. 101

    Patients

    Seq Age Sex Outcome Treatment
    1