BEUDAMED
    FDA Adverse Event Summary report: N

    DSD-201

    MDR report key: 6175491 · Received December 15, 2016

    Report

    Report Number
    2150060-2016-00051
    Date Received
    December 15, 2016
    Date of Event
    November 15, 2016
    Report Date
    December 14, 2016
    Manufacturer
    MEDIVATORS
    Product Code
    FEB
    PMA / PMN Number
    K914145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDIVATORS FIELD SERVICE ENGINEER DISCOVERED WHILE PERFORMING A PM ON A DSD-201 AER THAT THE FILTERS WERE NOT BEING CHANGED OUT IN ACCORDANCE TO THE AER IFU. IMPROPER FILTER AND MACHINE MAINTENANCE COULD LEAD TO IMPROPER ENDOSCOPE DISINFECTION, THUS POTENTIAL PATIENT HARM. MEDIVATORS FSE INFORMED THE CUSTOMER THE IMPORTANCE OF FILTER REPLACEMENT PER MACHINE MAINTENANCE GUIDELINES AND DOCUMENTING APPROPRIATELY. TO DATE, THERE HAVE BEEN NO REPORTED PATIENT ILLNESS OR INJURY. THIS COMPLAINT WILL CONTINUE TO BE MAINTAINED WITHIN MEDIVATORS COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    MEDIVATORS FIELD SERVICE ENGINEER DISCOVERED WHILE PERFORMING A PM ON A DSD-201 THAT THE FILTERS WERE NOT BEING CHANGED OUT IN ACCORDANCE TO THE IFU. IMPROPER FILTER AND MACHINE MAINTENANCE COULD LEAD TO IMPROPER ENDOSCOPE DISINFECTION, THUS POTENTIAL PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825973 DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR FEB MEDIVATORS

    Patients

    Seq Age Sex Outcome Treatment
    1