BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DSD-201

    MDR report key: 8180582 · Received December 19, 2018

    Report

    Report Number
    2150060-2018-00081
    Event Type
    Injury
    Date Received
    December 19, 2018
    Date of Event
    November 21, 2018
    Report Date
    December 19, 2018
    Manufacturer
    MEDIVATORS
    Product Code
    FEB
    UDI-DI
    00677964033858
    PMA / PMN Number
    K914145
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    MEDIVATORS FIELD SERVICE ENGINEER (FSE) REPORTED DURING A SERVICE VISIT FOR A FACILITY'S DSD-201 AUTOMATED ENDOSCOPE RE-PROCESSOR (AER), THAT THE AER WAS MODIFIED BY ADDING A SWITCH TO SHUT OFF THE COMPRESSOR. THIS MODIFICATION IS NOT PART OF THE DESIGN SPECIFICATIONS FOR THE AER, THUS THE FACILITY IS USING THE DEVICE OFF-LABEL WHICH COULD PRESENT POTENTIAL USER HARM. IT WAS REPORTED THAT THE THIRD PARTY MANAGING SERVICE COMPANY ADDED A SWITCH FOR THE COMPRESSOR AFTER NOT BEING ABLE TO FIND A SUSPECTED AIR LEAK. THE SWITCH ALLOWS OPERATORS TO SHUT OFF THE COMPRESSOR AND KEEP IT FROM BURNING OUT. MEDIVATORS FSE FIXED THE AIR LEAK DURING THE SERVICE CALL AND DID NOT NOTICE ANY OTHER VISIBLE MODIFICATIONS TO THE AER. MEDIVATORS TECHNICAL SPECIALIST MANAGER REPORTED CONCERNS THAT THE TYPE OF SWITCH USED IS NOT APPROPRIATE FOR THE APPLICATION OF THIS DEVICE. IF OPERATORS MAKE CONTACT WITH WET, GLOVED HANDS, THERE IS POTENTIAL TO RECEIVE AN ELECTRICAL SHOCK. THERE HAVE BEEN NO REPORTS OF USER HARM. THIS AER IS NORMALLY SERVICED AND MAINTAINED BY A THIRD PARTY SERVICE COMPANY, MEDSERVICE REPAIR, INC. IT IS THE FACILITY'S RESPONSIBILITY TO ENSURE THE MACHINE IS PROPERLY SERVICED AND OPERATING ACCORDING TO MEDIVATORS SPECIFICATIONS. THIS COMPLAINT WILL CONTINUE BEING MONITORED IN MEDIVATORS COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    MEDIVATORS FIELD SERVICE ENGINEER REPORTED DURING A SERVICE VISIT FOR A FACILITY'S DSD-201 AUTOMATED ENDOSCOPE RE-PROCESSOR, THAT THE AER WAS MODIFIED BY ADDING A SWITCH TO SHUT OFF THE COMPRESSOR. THIS MODIFICATION IS NOT PART OF THE DESIGN SPECIFICATIONS FOR THE AER, THUS THE FACILITY IS USING THE DEVICE OFF-LABEL WHICH COULD PRESENT POTENTIAL USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018056 DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR FEB MEDIVATORS 00677964033858

    Patients

    Seq Age Sex Outcome Treatment
    1 Other