BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH DEFINITION LCD MONITOR

    MDR report key: 10429273 · Received August 19, 2020

    Report

    Report Number
    8010047-2020-05624
    Event Type
    Malfunction
    Date Received
    August 19, 2020
    Report Date
    November 18, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FET
    PMA / PMN Number
    K102379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE EXACT CAUSE OF THE REPORTED PHENOMENON COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, BASED UPON THE INFORMATION FROM OLYMPUS EUROPA SE & CO. KG (OEKG) THERE WAS THE POSSIBILITY THAT THE REPORTED PHENOMENON WAS ATTRIBUTED TO THE ACCIDENTAL FAILURE OF THE POWER CIRCUIT BOARD. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE SUPPLEMENTED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IN THIS REPORT HAS NOT BEEN RETURNED TO OMSC FOR 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 FROM THE USER THAT THE SUBJECT DEVICE DID NOT FUNCTION DURING A FREEZING BRONCHOSCOPY IN THE INTENSIVE CARE UNIT. THE USER COULD NOT COMPLETE THE PROCEDURE. THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) (OEKG) CHECKED THE SUBJECT DEVICE AND FOUND THAT THE REPORTED ISSUE WAS DUPLICATED AND THE ELECTRICAL CIRCUIT BOARD OF THE POWER SUPPLY HAD FAILURE, ALSO THE IMAGE WAS NOT DISPLAYED. HOWEVER THERE WAS NO DAMAGE ON THE EXTERIOR OF THE SUBJECT DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889149 HIGH DEFINITION LCD MONITOR HIGH DEFINITION LCD MONITOR FET OLYMPUS MEDICAL SYSTEMS CORP. OEV262H

    Patients

    Seq Age Sex Outcome Treatment
    1