BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS VIDEO PROCESSOR

    MDR report key: 1962585 · Received January 6, 2011

    Report

    Report Number
    1962585
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 30, 2010
    Report Date
    January 6, 2011
    Manufacturer
    OLYMPUS
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    TYPED CORRECT PATIENT DATA ONTO KEYBOARD BUT DID NOT DISPLAY ON PHOTOS WHAT WAS TYPED, IE, DATE, AGE, ETC.====================== HEALTH PROFESSIONAL'S IMPRESSION======================NO PATIENT HARM.====================== MANUFACTURER RESPONSE FOR VIDEO PROCESSOR, OLYMPUS VIDEO PROCESSOR======================FIELD REP SAID HE WOULD REPORT TO FDA. FIELD REP BROUGHT LOANER (B) (4). FIELD REP THOUGHT THE PROBLEM WAS WITH THE BATTERY, BUT DON'T HAVE MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPUS VIDEO PROCESSOR VIDEO PROCESSOR KOG OLYMPUS CV-160 *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR
    2 73 YR
    3 50 YR
    4 50 YR