BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 101 MONITOR

    MDR report key: 2060901 · Received March 14, 2011

    Report

    Report Number
    1828100-2011-00626
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 7, 2011
    Report Date
    March 14, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTY
    PMA / PMN Number
    K902654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    DURING PREVENTATIVE MAINTENANCE OF THE DEVICE, THE USER REPORTED THAT THE MONITOR DEMONSTRATED AN INTERMITTENT COMMUNICATION PROBLEM WITH THE INTERFACE MODULE. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE 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