BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAJ-1655 OEV-261H PSU HOLDER

    MDR report key: 17455287 · Received August 3, 2023

    Report

    Report Number
    9611174-2023-00028
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    July 10, 2023
    Report Date
    September 25, 2023
    Manufacturer
    KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD
    Product Code
    FEM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION AND FOLLOW UP WITH THE USER FACILITY IS CURRENTLY BEING PERFORMED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE; HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, AND SINCE THE MEDICAL FACILITY RESOLVED THE ISSUE TO THEIR OWN SATISFACTION, IT IS LIKELY THE ISSUE WAS CAUSED BY INCORRECT INSTALLATION OR COMMISSIONING OF THE POWER SUPPLY UNIT WHEN PLACING IT WITHIN MAJ-1655 OR INCORRECT INSTALLATION OF THE MONITOR CABLING. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS, THE OEV-261H MONITOR AND AUXILLARY MONITOR ARE BLACK. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THE PRODUCT WILL NOT BE RETURNED AS THE ISSUE WAS RESOLVED. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280385 MAJ-1655 OEV-261H PSU HOLDER WORK STATION FEM KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD K10021654 7340431

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown