BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS KEYMED

    MDR report key: 3567767 · Received November 8, 2013

    Report

    Report Number
    9611174-2013-00012
    Event Type
    Malfunction
    Date Received
    November 8, 2013
    Date of Event
    October 15, 2013
    Report Date
    October 15, 2013
    Manufacturer
    KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
    Product Code
    FEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL INVESTIGATION BY OLYMPUS (B)(4) FIELD SERVICE ENGINEER FOUND A BURNT TRACE ON THE MAINS POWER SUPPLY OUTLET. ON EXAMINATION OF THE POWER CORD THE FIELD SERVICE ENGINEER FOUND THAT THE PIN OF THE PLUG WAS PHYSICALLY BENT. PHOTOGRAPHS OF THE DAMAGED COMPONENT HAVE BEEN SUBMITTED FOR EXAMINATION TO KEYMED. KEYMED AS THE MFR (OF THE WORKSTATION) HAVE REQUESTED THE RETURN OF THE POWER CABLE AND PLUG FOR A FULL INVESTIGATION. HOWEVER, THE DAMAGE SHOWN IN PHOTO IS CONSISTENT WITH A BROKEN PIN INSIDE THE PLUG MOULDING, MOST PROBABLY CAUSED BY ATTEMPTING TO MOVE THE WORKSTATION TO ANOTHER LOCATION WHILE IT IS STILL CONNECTED TO THE MAINS SUPPLY. THIS EVENT IS ALREADY CAUTIONED AGAINST IN THE INSTRUCTIONS FOR USE FOR THE WORKSTATION. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE OLYMPUS MOBILE WORKSTATION IS DESIGNED TO BE USED WITH A RANGE OF OLYMPUS EQUIPMENT TO FACILITATE GI ENDOSCOPY, ENDOSCOPIC ULTRASOUND, RESPIRATORY AND SURGICAL ENDOSCOPIC PROCEDURES. THERE WAS NO PT INVOLVEMENT IN THIS EVENT. THERE WAS NO PROCEDURE TAKING PLACE DURING THIS EVENT THIS EVENT TOOK PLACE DURING AN INSPECTION BY AN OLYMPUS FIELD SERVICE ENGINEER AT THE HEALTHCARE FACILITY. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION. THE FOLLOWING DEVICES WERE ON THE WORKSTATION: CV-260 VIDEO SYSTEM CENTER, CLV-206 LIGHT SOURCE, AN OEP-4 VIDEO PRINTER, IT-1, OEV191H LCD DISPLAY, AND A SONY DVD. WHEN THE FIELD SERVICE ENGINEER TURNED ON THE POWER TO THE LIGHT SOURCE, SMOKE OCCURRED BETWEEN THE PLUS OF THE WORKSTATION TRANSFORMER AND THE MAIN POWER SUPPLY SOCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579669 OLYMPUS KEYMED OLYMPUS KEYMED MOBILE WORKSTATION FEM KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. WM-NP1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA AN OEP-4 VIDEO PRINTER| CLV-206 LIGHT SOURCE| OEV191H LCD DISPLAY| CV-260 VIDEO SYSTEM CENTER| SONY DVD| IT-1