BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 3883305 · Received February 20, 2014

    Report

    Report Number
    8010047-2014-00058
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 24, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    NWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE PROCEDURE, THE SUBJECT DEVICE WAS INSPECTED BY THE MEDICAL ENGINEER OF THE FACILITY. THE IMAGE OF THE SUBJECT DEVICE APPEARED AT THAT TIME, BUT IT WAS PLANNED TO RETURN TO OLYMPUS FOR INSPECTION AND REPAIR. THERE WAS NO IRREGULARITY OF THE SUBJECT DEVICE WITH THE DEVICE HISTORY RECORD. BECAUSE OF THE HOLE IN THE SALINE PACK WHICH WAS MADE BY THE IMPROPER HANDLING OF THE FACILITY, THE ELECTRICAL CIRCUIT INSIDE THE SUBJECT DEVICE BECAME WET WITH THE SALINE, BECAME SHORT STATE, AND EVENTUALLY THE SUBJECT DEVICE BECAME NOT FUNCTIONING PROPERLY. SEE SCANNED PAGE. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT DURING AN ESOPHAGEAL TUMOR RESECTION WITH THE SUBJECT DEVICE (OEV261H) AND OTHER DEVICES SET ON A WORKING STATION, WHEN A SALINE PACK WAS PRESSURIZED AND HANG ON THE WORKING STATION'S HANGER FOR CABLES, A HOLE WAS MADE ON THE PACK AND SALINE WAS POURED ON THE SUBJECT DEVICE AND OTHER DEVICES. IT CAUSED THE DISAPPEARANCE OF IMAGE ON THE MONITOR OF THE SUBJECT DEVICE. THE SET OF THE WORKING STATION INCLUDING THE SUBJECT DEVICE WAS REPLACED TO ANOTHER SET OF WORKING STATION, AND THE PROCEDURE WAS CONTINUED AND COMPLETED. THERE WAS NO PT OR MEDICAL STAFF INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106809 HIGH DEFINITION LCD MONITOR LCD MONITOR NWB OLYMPUS MEDICAL SYSTEMS CORPORATION OEV261H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other