BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS WM-NP2 WORKSTATION

    MDR report key: 3983456 · Received July 7, 2014

    Report

    Report Number
    9611174-2014-00007
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
    Product Code
    FEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE POWER CORD AND PLUG WILL BE RETURNED TO THE OLYMPUS (B)(4). AT THIS TIME, KEYMED DO NOT HAVE VISUAL IMAGES OF THE POWER CORD AND PLUG WITH WHICH TO CONDUCT AN INITIAL INVESTIGATION. KEYMED HAVE REQUESTED THE RETURN OF THE POWER CORD AND PLUG TO ENABLE US TO CONDUCT A FULL INVESTIGATION. THERE IS NO REPORT OF PATIENT INJURY AND THIS REPORT IS SUBMITTED IN AN ABUNDANCE OF CAUTION BASED ON THE INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    OLYMPUS WORKSTATIONS ARE DESIGNED FOR USE WITH A RANGE OF OLYMPUS EQUIPMENT TO FACILITATE ENDOSCOPY PROCEDURES. KEYMED LTD. HAS BEEN MADE AWARE THAT BEFORE AN UNKNOWN PROCEDURE THE FACILITY STAFF AT THE HOSPITAL CONNECTED THE POWER CORD TO THE POWER OUTLET AND TURNED ON THE WORKSTATION. THE WORKSTATION DID NOT POWER UP AND THE LED ON THE REMOTE SWITCH DID NOT ILLUMINATE. THE FIELD SERVICE ENGINEER INSPECTED THE POWER CABLE AND FOUND THERE WAS A BURN MARK. ADDITIONALLY, THE BREAKER OF THE WORKSTATIONS TRANSFORMER WAS OFF. THERE IS NO REPORT OF PATIENT INJURY AND THIS REPORT IS SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394915 OLYMPUS WM-NP2 WORKSTATION MOBILE WORKSTATION, 876.1500 FEM KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. WM-NP2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UCR| AMM215WTD| CV-290| CLV-290