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

Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Electric Shock (2554); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: DSD-201
• Common Device Name: AUTOMATED ENDOSCOPE REPROCESSOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 8180582
• Report Number: 2150060-2018-00081
• Device Sequence Number: 11268714
• 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): 12/19/2018

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2018
• Initial Report FDA Received Date: 12/19/2018
• 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