BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIVATORS

    MDR report key: 1702256 · Received May 28, 2010

    Report

    Report Number
    2150060-2010-00123
    Event Type
    Malfunction
    Date Received
    May 28, 2010
    Report Date
    May 17, 2010
    Manufacturer
    MEDIVATORS REPROCESSING SYSTEMS, DIV. OF MINNTECH
    Product Code
    FEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2010 - MINNTECH SALES REPRESENTATIVE (MSR) VISITED THE FACILITY TO DISCUSS REPLACING HIS DSD-91E. WHILE THERE, THE MSR WENT INTO THE REPROCESSING ROOM TO INSPECT THE 91E AND THEIR HOOK-UPS. THE MSR WENT INTO SET 5 AND OBSERVED THAT IT WAS SET TO A 20 MINUTE SOAK TIME. THE MSR EXPLAINED TO THE DOCTOR THAT HIS DSD-91E HAD A 20 MINUTE SOAK TIME AND IT COULD BE CHANGED TO 5 MINUTES. SHE ALSO STATED THAT THEIR HOOK-UPS WERE ALTERED AND NEEDED TO BE REPLACED. THE CLINIC AGREED TO ORDER NEW HOOK-UPS. THE DOCTOR WENT WITH THE MSR TO CHANGE THE PROGRAM ON THE DSD-91E. THE MSR WAS ON THE PHONE WITH MINNTECH TECHNICAL SUPPORT THAT WALKED HER THROUGH THE PROCESS. WHEN SHE WAS DONE SHE CALLED THE MINNTECH SALES CONSULTANT AND REVIEWED THE PROGRAM WITH HER. ON (B)(4) 2010 - MINNTECH MSR RETURNED TO THE CLINIC OFFICE TO DISCUSS AN ORDER THAT WAS PLACED. NO CONTACT WITH THE DSD-91E ON THIS VISIT. THIS WAS THE LAST VISIT FROM A MINNTECH REPRESENTATIVE UNTIL (B)(4) 2010. ON (B)(4) 2010 - OLYMPUS FIELD SERVICE ENGINEER (FSE) OBSERVED AND COACHED NEW ESS, WHILE GIVING CDS IN-SERVICE AT THE FACILITY. WHILE THERE THE OLYMPUS FSE SET THE CORRECT PROGRAM. AND SPOT CHECKED SCOPES AND CAPS. ON (B)(4) 2010 - OLYMPUS FSE VISITED THE FACILITY, WHILE THERE HE WAS ASKED TO CHECK THE PROGRAM IN THE DSD-91E BECAUSE A REPRESENTATIVE FROM (B)(4) HAD BEEN THERE RECENTLY AND MADE CHANGES TO THE PROGRAM, THEY WANTED TO MAKE SURE IT WAS CORRECT. THE OLYMPUS FSE FOUND THAT THE FILL TIME FOR THE HLD HAD BEEN ELIMINATED. HE RAN A TEST CYCLE AND FOUND THAT THE PROCESS WENT FROM FLUSH STRAIGHT TO A RINSE AND BYPASSED THE HLD CYCLE DO TO THE FILL TIME BEING ZERO'D OUT. THE FSE CORRECTED THE PROGRAM BY ADDING 4 MINUTES AND 30 SECONDS TO THE FILL TIME. THE PROGRAM WAS TESTED BY RUNNING A TEST CYCLE. TESTING PASSED. ON (B)(4) 2010 - MINNTECH FIELD SERVICE ENGINEER (FSE) AND THE MINNTECH SALES REPRESENTATIVE VISITED THE FACILITY TO REVIEW THE PRINT OUT AND CHECK THE PROGRAM PARAMETERS. THE CUSTOMER HAS NOT BEEN PRINTING DAILY LOGS. DATA WAS ATTEMPTED TO BE RETRIEVED, HOWEVER, LOGS WERE INVALID FROM (B)(4) 2009 THROUGH (B)(4) 2010. THE DATA ON THE PRINT OUT IS IN CONCLUSIVE. NO DATA TO PROVE WHEN IT WAS INCORRECTLY SET. THE CURRENT PROGRAM IS SET PER CUSTOMERS SPECIFICATIONS. NO PATIENT INJURIES REPORTED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    AN OLYMPUS FIELD SERVICE ENGINEER (FSE) VISITED THE FACILITY; WHILE THERE HE WAS ASKED TO CHECK THE PROGRAM. THE OLYMPUS FSE FOUND THAT THE FILL TIME FOR THE HLD HAD BEEN ELIMINATED. HE RAN A TEST CYCLE AND FOUND THAT THE PROCESS WENT FROM FLUSH STRAIGHT TO A RINSE AND BYPASSED THE HLD CYCLE, DUE TO THE FILL TIME BEING ZERO'D OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDIVATORS ENDOSCOPE DISINFECTOR FEB MEDIVATORS REPROCESSING SYSTEMS, DIV. OF MINNTECH DSD-91E

    Patients

    Seq Age Sex Outcome Treatment
    1 Other