BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 14626355 · Received June 7, 2022

    Report

    Report Number
    8010047-2022-09584
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Report Date
    July 25, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    UDI-DI
    04953170363498
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING TROUBLESHOOT VIA TELEPHONE, IT WAS DETERMINED THAT THE CIRCUIT BOARD ON THE MONITOR WAS DAMAGED WHICH THE CUSTOMER SUSPECTED WAS ATTRIBUTED TO A POWER SURGE. THE REFERENCED DEVICE WAS RETURNED TO OLYMPUS FOR SERVICE. THE SERVICE INSPECTION CONFIRMED THE CUSTOMER¿S REPORTED PROBLEM AS THERE WAS NO POWER FROM A DEFECTIVE/FAULTY CIRCUIT (GI) BOARD. THE CIRCUIT BOARD WAS REPLACED, AND THE DEVICE WAS TESTED AND FUNCTIONED APPROPRIATELY. THE INVESTIGATION IS ONGOING; THEREFORE, THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED AT THIS TIME. HOWEVER, IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS MEDICAL DEVICE REPORT WILL BE SUPPLEMENTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 5 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, THE INVESTIGATION CONFIRMED THE DEVICE WOULD NOT POWER ON DUE TO A FAULTY PRINTED CIRCUIT BOARD. THE SPECIFIC ROOT CAUSE OF THE FAULTY PRINTED CIRCUIT BOARD COULD NOT BE DETERMINED AT THIS TIME. MINOR SCRATCHES WERE ALSO NOTED ON THE LIQUID CRYSTAL DISPLAY WINDOW SCREEN; HOWEVER, THIS DEFECT IS NOT CONSIDERED SEVERE ENOUGH TO CAUSE A POTENTIAL ADVERSE EVENT. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    THE TECHNICAL SUPPORT ENGINEER WAS INFORMED BY THE BIOMEDICAL EQUIPMENT TECHNICIAN AT THE USER FACILITY THAT CUSTOMER HIGH-DEFINITION LIQUID CRYSTAL DISPLAY MONITOR IS ¿NOT POWERING ON¿. THE PROBLEM WAS FOUND DURING PREPARATION FOR USE. NO DEATH, INJURY OR HARM WAS REPORTED TO OLYMPUS. THE DEVICE WILL BE RETURNED FOR SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141561 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H 04953170363498

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown