BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAJ-1641 LCD MONITOR ARM IPF-2

    MDR report key: 8959327 · Received September 4, 2019

    Report

    Report Number
    9611174-2019-00017
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    August 22, 2019
    Report Date
    October 9, 2019
    Manufacturer
    KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.
    Product Code
    FEM
    PMA / PMN Number
    CLASS 1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    OLYMPUS KEYMED PASSED THE INVESTIGATION TO THE SUPPLIER OF THE PART (SOUTHCO) TO INVESTIGATE FURTHER. HOWEVER, THE MONITOR ARM WAS DISCARDED AND SOUTHCO ARE NOT ABLE TO PROCEED WITH THE INVESTIGATION. MANUFACTURING RECORDS WERE REVIEWED BY THE SUPPLIER OF THE MONITOR ARM AND NO ISSUES COULD BE IDENTIFIED. IF A REPEAT FAILURE IS LOGGED WITH OLYMPUS KEYMED, KEYMED'S SUPPLIER HAS RECOMMENDED THAT THE PART BE RETAINED AND RETURNED TO OLYMPUS TO ENABLE A DETAILED INVESTIGATION TO BE CARRIED OUT. THIS WILL BE THE FINAL FOLLOW UP REPORT. IF ANY NEW INFORMATION IS PROVIDED TO OLYMPUS KEYMED THE PAE CASE WILL BE REVIEWED AND AN UPDATED FOLLOW-UP REPORT SHALL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    NO REPORT OF INJURY TO PATIENT OR USER. OLYMPUS KEYMED HAVE REQUESTED THAT THE PRODUCT IS RETURNED FOR FURTHER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE KEYMED INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    AT THE END OF THE SURGERY OPERATION, A NURSE TRIED TO MOVE THE ENDOSCOPIC CART WM-NP2. THE LCD MONITOR ARM DISENGAGED ALONG WITH THE LCD MONITOR AND FELL OFF. ANOTHER NURSE THAT WAS STANDING NEXT TO THE WORKSTATION WAS ABLE TO GRAB HOLD OF THE ARM AND PLACE IT ON THE TOP SHELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753690 MAJ-1641 LCD MONITOR ARM IPF-2 WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS FEM KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. K10016875

    Patients

    Seq Age Sex Outcome Treatment
    1