BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 10217487 · Received July 1, 2020

    Report

    Report Number
    8010047-2020-03789
    Event Type
    Malfunction
    Date Received
    July 1, 2020
    Date of Event
    June 9, 2020
    Report Date
    September 10, 2020
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    UDI-DI
    04953170324147
    PMA / PMN Number
    K122180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE THE SUBJECT DEVICE EVALUATION RESULT. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) BUT WAS RETURNED TO OLYMPUS VIETNAM (OVN) FOR EVALUATION. BASED ON THE EVALUATION OF THE OVN, THE CAUSE OF THE REPORTED EVENT WAS THE MALFUNCTION OF THE PRINTED-CIRCUIT BOARD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE FACILITY THAT THE SUBJECT DEVICE DID NOT FUNCTION DURING PREPARATION BEFORE AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) CHECKED THE SUBJECT DEVICE AND FOUND THAT THE SUBJECT DEVICE COULD NOT FUNCTION AND COULD NOT STOP THE ALARM SOUND DUE TO THE DAMAGE OF THE ELECTRICAL CIRCUIT BOARD. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683646 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-4 04953170324147

    Patients

    Seq Age Sex Outcome Treatment
    1