BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR

    MDR report key: 14117295 · Received April 15, 2022

    Report

    Report Number
    2150060-2022-00023
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Date of Event
    March 16, 2022
    Report Date
    April 15, 2022
    Manufacturer
    MEDIVATORS, INC.
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 THE GROUND FAULT INTERRUPTER (GFI) WAS CHARRED. THROUGH FURTHER INSPECTION, THE TECHNICIAN FOUND THAT THE UNIT WAS LEAKING FROM A CRACKED OVERFLOW COUPLING. THE GFI BECAME WET DUE TO THE LEAK RESULTING IN THE REPORTED EVENT. THE DSD EDGE HAS BEEN DESIGNED WITH FIRE-RESISTANT MATERIALS AND ANY THERMAL EVENTS WHICH OCCUR INTERNAL TO THE UNIT ARE EXPECTED TO BE CONTAINED AND NOT TO TRAVEL OUTSIDE OF THE UNIT. FURTHERMORE, THE SERVICE MANUAL PROVIDES THE FOLLOWING WARNING LANGUAGE FOR THE GFI AND POTENTIAL THERMAL EVENTS: "TO AVOID INJURY OR DEATH FROM AN ELECTRICAL INSULATION BREAKDOWN WITHIN THE UNIT, THE GFI (GROUND FAULT INTERRUPTER) CIRCUIT BREAKER SHOULD BE CHECKED FOR PROPER OPERATION ON AN ANNUAL BASIS. IF DURING THE USE OF THIS EQUIPMENT YOU SEE OR SMELL SMOKE, IMMEDIATELY DISCONNECT THE UNIT FROM THE POWER SUPPLY, DISCONTINUE USE AND CALL MEDIVATORS TECHNICAL SUPPORT." THE AER SUBJECT OF THIS REPORT WAS INSTALLED IN 2011 MAKING IT APPROXIMATELY 11 YEARS OLD. THE TECHNICIAN MADE THE NECESSARY REPAIRS, 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 SMOKE WAS EMITTING FROM INSIDE THEIR DSD EDGE AER. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140519 DSD EDGE AUTOMATED ENDOSCOPE REPROCESSOR ENDOSCOPE REPROCESSING SYSTEM FEB MEDIVATORS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown