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

Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A biomedical technician reported that while on site servicing a facility's dsd-201 automated endoscope reprocessor (aer), the basin temperature of the aer had the incorrect temperature settings per the rapicide high-level disinfectant being used.There is a potential that endoscopes reprocessed in the aer were not adequately high-level disinfected, thus there is a potential for patient harm.The facility uses rapicide high-level disinfectant in their aer machine which has a contact time of 5 minutes at 35°c.The facility's aer was set to 31°c due to receiving a temperature error at the recommended temperature setting.The technician adjusted the minimum basin temperature to 36°c and a maximum of 42°c.There have been no additional reports of the temperature error since the technician has adjusted the settings.Per the medivators dsd-201 user manual, users are required to verify the correct parameter settings for the type of hld being used.It is unknown how long the aer had the incorrect settings and the number of endoscopes that were reprocessed.There have been no reports of patient harm.This complaint will continue being monitored in the medivators complaint handling system.
Event or Problem Description
A biomedical technician reported that while on site servicing a facility's dsd-201 automated endoscope preprocessor (aer), the basin temperature of the aer had the incorrect temperature settings per the rapicide high-level disinfectant being used.There is a potential that endoscopes reprocessed in the aer were not adequately high-level disinfected, thus there is a potential for patient 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: 8923159
• Report Number: 2150060-2019-00060
• Device Sequence Number: 16656028
• Product Code: FEB
• UDI-Device Identifier: 00677964033858
• UDI-Public: 00677964033858
• Combination Product (Y/N): N
• PMA/510(K) Number: K914145
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 08/22/2019

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: No Information
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/22/2019
• 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