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

Model Number	DSD-201 120V
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medivators field service engineer (fse) reported a facility had their basin temperature set below the minimum requirement for a dsd 201 automated endoscope repocessor (aer).There is potential that endoscopes were not adequately high level disinfected.Medivators fse reported the facility was using cidex opa high level disinfect (hld).The temperature for was set below the minimum requirement and the heater on side a was turned off.The fse adjusted the temperature and turned the side heater on.The fse also found that an air filter on side b was installed backwards and lid cylinders needed urgent replacement.The fse made necessary adjustments and completed test cycles.The aer performed according to specification.The aer was installed in 2003.There is no indication that the aer malfunctioned.Per the medivators dsd-201 user manual, users are required to verify the correct parameter settings for the type of hld being used.The aer was last serviced (b)(6) 2018 by medivators fse and was found to be performing to specification.It is unknown at what point the incorrect temperature settings were made and the number of endoscopes that were reprocessed.There have been no reports of patient harm.This complaint will be monitored in the medivators complaint handling system.
Event or Problem Description
Medivators field service engineer (fse) reported a facility had their basin temperature set below the minimum requirement for a dsd 201 automated endoscope repocessor (aer).There is potential that endoscopes were not adequately high level disinfected.

• Brand Name: DSD-201
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; plymouth, mn
• MDR Report Key: 9774454
• Report Number: 2150060-2020-00008
• Device Sequence Number: 1828236
• Product Code: FEB
• UDI-Device Identifier: 00677964033858
• UDI-Public: 00677964033858
• Combination Product (Y/N): N
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2020

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
• Device Model Number: DSD-201 120V
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 03/02/2020
• 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