BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SSD-201 AUTOMATED ENDOSCOPE REPROCESSOR

    MDR report key: 14462305 · Received May 20, 2022

    Report

    Report Number
    2150060-2022-00028
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    April 25, 2022
    Report Date
    May 20, 2022
    Manufacturer
    MEDIVATORS, INC.
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A MEDIVATORS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT AND FOUND THAT THE WATER LEAK WAS COMING FROM THE ELBOW FITTING UNDER THE FILTER HOUSING. THE TECHNICIAN REPLACED THE ELBOW FITTING, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THEIR SSD-201 AUTOMATED ENDOSCOPE REPROCESSOR WAS LEAKING WATER ONTO THE FLOOR. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368037 SSD-201 AUTOMATED ENDOSCOPE REPROCESSOR ENDOSCOPE REPROCESSING SYSTEM FEB MEDIVATORS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown