BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 2527105 · Received March 7, 2011

    Report

    Report Number
    2518897-2011-00002
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Report Date
    February 26, 2011
    Manufacturer
    PENTAX MEDICAL COMPANY
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED: UPON STARTING A ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH THE DOCTOR, HE ATTEMPTED TO CAPTURE PICTURES AND I NOTICED THAT IT SAID CAPTURE OKAY, BUT THE PICTURES WERE BLACK AND IT TRULY WAS NOT CAPTURING THE COLOR PICTURES. I ATTEMPTED TO REBOOT THE PROCESSOR IN AN ATTEMPT TO RECTIFY THE PROBLEM. I ALSO CHECKED ALL THE CONNECTIONS TO THE PROCESSOR AND CHECKED TO MAKE SURE IT WAS ON THE RIGHT VIEWING CHANNEL AS PREVIOUSLY INSTRUCTED TO DO SO BY CLINICAL ENGINEERING. NOTE - THE USER REPORT INDICATED EVENT DATE (B)(6) 2011, THIS MUST BE AN ERROR AS PENTAX RECEIVED THE USER REPORT FROM FDA (B)(4) 2011. REFERENCE USER FACILITY REPORT # (B)(4). UNIT EVALUATED AT USER FACILITY (B)(4) 2011; POSSIBLE CABLE FAILURE - USER REINSTRUCTED IN PROPER CABLING AND TROUBLESHOOTING. POSSIBLE USER ERROR - USER REINSTRUCTED IN PROPER USE OF AUXILIARY SWITCHING BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTAX VIDEO PROCESSOR FDS PENTAX MEDICAL COMPANY EPK-I *

    Patients

    Seq Age Sex Outcome Treatment
    1 *