BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO CDI 101 MONITOR

    MDR report key: 1981611 · Received January 31, 2011

    Report

    Report Number
    1828100-2011-00082
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 31, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTY
    PMA / PMN Number
    K902654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING FIELD SERVICE INSTALLATION OF THE DEVICE, THE USER REPORTED TWO FLASH CARDS FAILED AND DISPLAYED A "FAULT 5" ERROR MESSAGE. NO OTHER DETAILS REGARDING THE NATURE OF THE EVENT WERE PROVIDED. SINCE THIS EVENT OCCURRED DURING FIELD SERVICE INSTALLATION, 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