BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM

    MDR report key: 14462084 · Received May 20, 2022

    Report

    Report Number
    2150060-2022-00027
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    April 20, 2022
    Report Date
    May 20, 2022
    Manufacturer
    MEDIVATORS, INC.
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AIR COMPRESSOR DELIVERS PROPER AIR FLOW AND PRESSURE FOR CORRECT SYSTEM OPERATION. THE USER FACILITY'S BIOMED DEPARTMENT INSPECTED THE UNIT AND FOUND THERE WAS AN AIR LEAK AT THE LID CONTROL VALVE OF THE ADVANTAGE PLUS. THE AIR LEAK SUBSEQUENTLY CAUSED THE COMPRESSOR TO OVERHEAT RESULTING IN THE REPORTED EVENT. THE ADVANTAGE PLUS WAS INSTALLED IN 2016 AND IS NOT UNDER MEDIVATORS SERVICE AGREEMENT FOR MAINTENANCE ACTIVITIES; THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. THE USER FACILITY ELECTED TO PERFORM THE REPAIRS TO THEIR UNIT AND RETURNED THE UNIT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE AIR COMPRESSOR TO THEIR ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM OVERHEATED AND PARTS SEPARATED FROM THE COMPRESSOR. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564478 ADVANTAGE PLUS ENDOSCOPE REPROCESSING SYSTEM ENDOSCOPE REPROCESSING SYSTEM FEB MEDIVATORS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown