BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WM-NP1 220-240V ROW

    MDR report key: 7262613 · Received February 11, 2018

    Report

    Report Number
    9611174-2018-00004
    Event Type
    Malfunction
    Date Received
    February 11, 2018
    Date of Event
    February 1, 2018
    Report Date
    March 19, 2018
    Manufacturer
    KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
    Product Code
    FEM
    PMA / PMN Number
    PCLASS 1
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO REPORT OF INJURY TO PATIENT OR USER. FIELD SERVICE ENGINEER (FSE) HAS ATTENDED AND CARRIED OUT FULL TESTING. NO FAULT FOUND, AND HAS ADVISED THAT WM-NP1 TROLLEY AND AN OFP-2 (FLUSHING PUMP) WHICH WAS BEING USED DURING THE SAME PROCEDURE ((B)(4)) IS FIT FOR USE. FSE EXPLANATION FOR THE FAULT IS A TEMPORARY INTERRUPTION IN THE ROOM POWER. REPORTED IN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER, AS AN OLYMPUS FIELD SERVICE ENGINEER HAS ATTENDED THE HEALTHCARE FACILITY AND TESTED THE SUBJECT DEVICE. THE FIELD SERVICE ENGINEER FOUND NO FAULT WITH THE SUBJECT DEVICE. INVESTIGATION INTO THIS EVENT WILL BE CLOSED HOWEVER IF ANY NEW INFORMATION IS PROVIDED THE INVESTIGATION WILL BE RE-OPENED. THIS EVENT IS REPORTED IN AN ABUNDANCE OF CAUTION. THIS WILL BE THE FINAL FOLLOW UP REPORT.

    Description of Event or Problem · 1

    RED LINES ON SCREEN AND SPARKS COMING FROM BACK OF MACHINE, SCREEN WENT BLANK. ABANDONED PROCEDURE. (B)(6) 2018 - JRB - UPDATE FROM FIELD SERVICE ENGINEER. HAS BEEN IN TODAY AND STRIPPED LIGHT SOURCE, PROCESSOR AND DONE ALL EXPECTED TESTS AND FOUND NO FAULT WITH OUR PRODUCT. MY ONLY EXPLANATION FOR THE FAULT IS A TEMPORARILY INTERRUPTION IN THE ROOM POWER. I HAVE SOAK TESTED THE PRODUCT FOR OVER AN HOUR WITH NO FAULT FOUND. I HAVE STATED TO (B)(6) (CHARGE NURSE), THE EQUIPMENT IN MY OPINION IS FIT FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105930 WM-NP1 220-240V ROW WM-*P1 SERIES OF ENDOSCOPY WORKSTATIONS FEM KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. K10000288

    Patients

    Seq Age Sex Outcome Treatment
    1