BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 10354592 · Received August 3, 2020

    Report

    Report Number
    8010047-2020-05154
    Event Type
    Malfunction
    Date Received
    August 3, 2020
    Report Date
    October 4, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. SINCE THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC), IT COULD NOT BE INVESTIGATED. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER BASED ON THE REPORT OF THE SERVICE DEPARTMENT OF OLYMPUS EUROPE SE & CO. KG (OEKG), OMSC SURMISED THERE WAS THE POSSIBILITY THIS PHENOMENON WAS ATTRIBUTED TO THE PRINTED CIRCUIT BOARD FAILURE OF THE SUBJECT DEVICE. THE PRINTED CIRCUIT BOARD FAILURE MIGHT BE OCCURRED BY THE ACCIDENTAL ELECTRONIC COMPONENT FAILURE OR THE COMPONENT DAMAGE DUE TO THE OVERCURRENT EFFECTS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    SINCE THE SUBJECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR THE EVALUATION, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THE SUBJECT DEVICE DIDN'T ACTIVATED WHEN THE SUBJECT DEVICE CONNECTED DIRECTLY THROUGH THE AC (ALTERNATING CURRENT) LINE DURING THE INSPECTION FOR THE REPAIR AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4). BUT THE SUBJECT DEVICE WAS WORKED WHEN THE SUBJECT DEVICE CONNECTED TO THE EXTERNAL POWER SUPPLY. THE SERVICE DEPARTMENT OF (B)(4) FOUND THE FAILURE OF THE PRINTED CIRCUIT BOARD WHICH CAUSED THE REPORTED PHENOMENON. AFTER THE INSPECTION, (B)(4) ALSO RECEIVED THE USER COMMENT THAT THE DEVICE HAD NOT BEEN USED FOR A WHILE UNDER CORONA PANDEMIC, BECAUSE THE TREATMENT ROOM TIMELY DISABLED WHERE THE SUBJECT DEVICE SET ON. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821202 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H

    Patients

    Seq Age Sex Outcome Treatment
    1