MAUDE Adverse Event Report: MEDIVATORS INC. DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR

Medical Device Problem Codes	Use of Device Problem (1670); Facilities Issue (2935)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medivators field service engineer visited the facility and discovered the sensors within the unit had been disabled and the unit was not programmed to the correct settings in accordance with the chemistry's instructions for use.The incorrect programming included: - only one rinse was set for the b-side reservoir.- the high and low reservoir sensors, temperature sensors and the sheath test on the b-side reservoir were all disabled.- the minimum temperature on the b-side was set to 10 degrees celsius.There is potential the endoscopes run under these settings were not properly disinfected or rinsed and therefore there is potential for patient cross-contamination or chemical colitis.The fse determined the settings had been incorrect since (b)(6) 2016.There was no communication or visits with medivators around the time the settings were modified.The facility reported there is a biomed on site who is trained to service the unit.The facility does not have a service agreement with medivators and thus there has been no preventative maintenance performed on the machine by medivators.The fse set the machine back to the correct settings and enabled all tests and sensors.The fse ran test cycles and ensured the unit was operating according to specifications.To date, there have been no reports of patient illness.This complaint will continue to be monitored within medivators complaint handling system.
Event or Problem Description
Medivators field service engineer visited the facility and discovered the sensors within the unit had been disabled and the unit was not programmed to the correct settings in accordance with the chemistry's instructions for use.There is potential the endoscopes reprocessed were not properly disinfected or rinsed, thus there is potential for patient cross-contamination or chemical colitis.

• Brand Name: DSD-201 AUTOMATED ENDOSCOPE REPROCESSOR
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 7000659
• Report Number: 2150060-2017-00046
• Device Sequence Number: 11150315
• Product Code: FEB
• UDI-Device Identifier: 00677964033858
• UDI-Public: 00677964033858
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K914145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Notification,Inspection
• Type of Report: Initial
• Report Date (Section B): 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other