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

Medical Device Problem Codes	Flushing Problem (1252); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During a service visit, a medivators field service engineer (fse) reported a facility had the incorrect water line disinfection (wld) cycle setting for their dsd-201 automated endoscope reprocessor (aer).There is a potential contamination risk from not performing the waterline disinfection for the required amount of time.The wld cycle was set to run for thirty minutes, instead of the required one hour, per the rapicide high level disinfectant instructions for use (ifu).The medivators fse informed the facility of the requirement to run the wld cycle for at least one hour per the rapicide ifu.The fse re-programmed the aer to run the wld cycle for one hour per specifications and showed the facility how to perform a wld with the correct settings.This aer was previously serviced by an unknown third-party company.Therefore, no information was provided to medivators regarding how long the wld cycle time was set incorrectly.There are no reported patient adverse events.This complaint will be monitored in the medivators complaint handling system.
Event or Problem Description
During a service visit, a medivators field service engineer (fse) reported a facility had the incorrect water line disinfection (wld) cycle setting for their dsd-201 automated endoscope reprocessor (aer).There is a potential contamination risk from not performing the waterline disinfection for the required amount of time.

• Brand Name: DSD-201
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 8332264
• Report Number: 2150060-2019-00014
• Device Sequence Number: 64717
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2019

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: Other
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 02/12/2019
• 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