BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS TC-V1

    MDR report key: 13544 · Received April 13, 1994

    Report

    Report Number
    2429304-1994-00045
    Event Type
    Malfunction
    Date Received
    April 13, 1994
    Report Date
    March 31, 1994
    Manufacturer
    OLYMPUS OPTICAL CO., LTD.
    Product Code
    HJG
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON TWO SEPERATE OCCASIONS, THE TC-V1 CART FELL OVER DURING TRANSPORT. IN EACH CASE, THE CART WAS BEING TRANSPORTED WITH TH EMONITOR ON THE TOP SHELF EVEN THOUGH IT STATES IN OUR LABELING THAT THE MONITOR SHOUILD BE REMOVED WHILE BEING TRANSPORTED. DURING ONE INCIDENT, THE RN SUSTAINED BRUISES TO HER LEG BUT IN TH ESECOND INCIDENT, THERE WASN'T ANY OCCURRENCE OF PERSONAL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS TC-V1 VIDEO CART HJG OLYMPUS OPTICAL CO., LTD. TC-V1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *