BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 11289885 · Received February 5, 2021

    Report

    Report Number
    8010047-2021-02296
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    January 11, 2021
    Report Date
    March 3, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    UDI-DI
    04953170363498
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER¿S FINAL INVESTIGATION. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION SO THE CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED. BASED ON THE LEGAL MANUFACTURER¿S INVESTIGATION, THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND THERE WERE NO PROBLEMS FOUND DURING THE MANUFACTURING OF THE DEVICE THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED ISSUE. THE DEVICE MET ALL SPECIFICATIONS AT THE TIME OF SHIPMENT.

    Additional Manufacturer Narrative · 1

    THE REPORTER INDICATED THAT THE POWER SUPPLY DID HAVE VOLTAGE AND THE LED WAS ILLUMINATED. THE REPORTER INDICATED THE ADAPTER IS LIKELY FROM ANOTHER MONITOR, MODEL #OEV-261H, AND INDICATED THAT THEY WILL ORDER THE POWER SUPPLY AND CORD SPECIFICALLY FOR THE SUBJECT DEVICE (OEV-262H).

    Description of Event or Problem · 1

    A USER FACILITY REPORTED TO OLYMPUS THAT THEIR MONITOR FAILED TO POWER ON. THERE WAS NO PATIENT INJURY OR HARM, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185383 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1