BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS WORKSTATION TRANSFORMER

    MDR report key: 3060875 · Received April 10, 2013

    Report

    Report Number
    9611174-2013-00003
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 8, 2013
    Manufacturer
    KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.
    Product Code
    FEM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL INVESTIGATION BY OLYMPUS (B)(4) CONFIRMED THAT THE SOLDER PART ON THE RIGHT HAND SIDE OF THE POWER SUPPLY OUTLET WAS DAMAGED BY SPARKS. THE PRODUCT HAS BEEN REVIEWED BY THE MFR AND HAS CONFIRMED THE DAMAGE IS CONSISTENT WITH THE USER NOT FULLY INSERTING THE MEDICAL DEVICE CONNECTORS INTO THE OUT PUT SOCKETS OF THE MOBILE WORKSTATION'S TRANSFORMER. THERE WAS NO REPORT OF INJURY AND THIS REPORT IS SUBMITTED IN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    THE OLYMPUS WM-T1 TRANSFORMER SERIAL NUMBER (B)(4), WAS MFG ON 08/15/2007, AND DELIVERED TO AND USED BY THE CUSTOMER SINCE (B)(6) 2007. THE UNDERSIDE OF THE BASE OF THE WM-NP1 MOBILE WORKSTATION IS DESIGNED WITH A PROTECTIVE METAL CRADLE INTO WHICH THE WM-T1 TRANSFORMER HAS 12 OUTPUT SOCKETS WHICH ALLOWS ELECTRICAL MEDICAL DEVICES, WHICH ARE SITUATED ON THE SHELVES OF WORKSTATION, TO BE PLUGGED INTO THE TRANSFORMER AND RECEIVE POWER WHEN THE MOBILE WORKSTATION IS CONNECTED TO THE MAINS SUPPLY. DURING THE EVENT, SPARKS OCCURRED AND THE POWER SUPPLY WAS SHUT OFF. THERE WAS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149918 OLYMPUS WORKSTATION TRANSFORMER MAJ-173 TRANSFORMER WM-T1 100V FEM KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. MAJ-173 2718567

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK