BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FLOW INSUFFLATION UNIT

    MDR report key: 12267114 · Received August 3, 2021

    Report

    Report Number
    8010047-2021-09713
    Event Type
    Malfunction
    Date Received
    August 3, 2021
    Date of Event
    July 14, 2021
    Report Date
    August 12, 2021
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    HIF
    PMA / PMN Number
    K122180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. WHEN THE LOCAL SERVICE DEPARTMENT CHECKED THE SUBJECT DEVICE, IT WAS FOUND THAT THE C TUBE WAS DAMAGED. THE EXACT CAUSE OF THE C TUBE DAMAGE COULD NOT BE CONCLUSIVELY DETERMINED BECAUSE THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. OMSC PRESUMED THAT IT WAS DAMAGED DUE TO HANDLING BECAUSE IT WAS NOT SHORTLY AFTER THE DELIVERY.

    Additional Manufacturer Narrative · 1

    LOCAL SERVICE DEPARTMENT CHECKED THE SUBJECT DEVICE AND FOUND THAT THE MAXIMUM AIR SUPPLY DIDN'T MEET THE STANDARD DUE TO FAULTY COMPONENTS. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. OMSC PRESUMED THAT THE MAXIMUM AIR SUPPLY DIDN'T MEET THE STANDARD DUE TO THE FAILURE OF THE PRIMARY DECOMPRESSOR. THE CAUSE OF THE FAILURE OF THE PRIMARY DECOMPRESSOR MIGHT BE A AGING DETERIORATION SINCE 7 YEARS AND 3 MONTHS HAVE PASSED SINCE MANUFACTURING.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT LOCAL SERVICE DEPARTMENT OF OLYMPUS, IT WAS FOUND THAT THE FOOT OF THE ELECTRODE VALVE WAS DAMAGED, AND THE PRESSURE REDUCING VALVE WAS MALFUNCTIONING AND THAT LEAD TO THE MAXIMUM AIR SUPPLY NOT MEETING THE STANDARD. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT. THIS DEVICE IS AN OLYMPUS ASSET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1168340 HIGH FLOW INSUFFLATION UNIT HIGH FLOW INSUFFLATION UNIT HIF OLYMPUS MEDICAL SYSTEMS CORP. UHI-4

    Patients

    Seq Age Sex Outcome Treatment
    1