MAUDE Adverse Event Report: MEDIVATORS, INC. DSD EDGE ENDOSCOPE REPROCESSING SYSTEM; DSD EDGE 120V

Model Number	78400-409
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility contacted medivators technical service (tsr) and reported a "no air flow" error message and non-operational compressor in station b of their medivators dsd edge unit.A medivators field service engineer was requested to be dispatched to the facility to investigate the reported event.No patient involvement was reported.The reported dsd edge unit was not used for endoscope reprocessing during the reported event.The user facility additionally submitted user facility medwatch report (b)(4) on november 16, 2021, following the reported event.
Additional Manufacturer Narrative
On october 13, 2020, the day after the request for service to the user facility was received, a medivators fse assessed the unit, replaced the fuse for the compressor and tested the unit, and confirmed it to be operating to specification.Additionally, following receipt of the medwatch report, medivators fse contacted the customer via phone call to inquire on the status of the unit and confirmed the unit to be operating according to specification.From the medivators dsd edge service manual (50097-027, rev e), the reported "no air flow" error will display when a loss of air flow to the unit is detected.This will result in a system interruption until air flow is restored.The reported unit was manufactured on june 24, 2015 and installed in july 2015.It is not under medivators service agreement; the facility is responsible for performing all maintenance of the unit.
Additional Manufacturer Narrative
On october 13, 2020, the day after the request for service to the user facility was received, a medivators fse assessed the unit, replaced the fuse for the compressor and tested the unit, and confirmed it to be operating to specification.Additionally, following receipt of the medwatch report, medivators fse contacted the customer via phone call to inquire on the status of the unit and confirmed the unit to be operating according to specification.From the medivators dsd edge service manual (50097-027, rev e), the reported "no air flow" error will display when a loss of air flow to the unit is detected.This will result in a system interruption until air flow is restored.The reported unit was manufactured on june 24, 2015 and installed in july 2015.It is not under medivators service agreement; the facility is responsible for performing all maintenance of the unit.
Event or Problem Description
The user facility contacted medivators technical service (tsr) and reported a "no air flow" error message and non-operational compressor in station b of their medivators dsd edge unit.A medivators field service engineer was requested to be dispatched to the facility to investigate the reported event.No patient involvement was reported.The reported dsd edge unit was not used for endoscope reprocessing during the reported event.The user facility additionally submitted user facility medwatch report (b)(4) on november 16, 2021, following the reported event.

• Brand Name: DSD EDGE ENDOSCOPE REPROCESSING SYSTEM
• Common Device Name: DSD EDGE 120V
• Manufacturer (Section D): MEDIVATORS, INC.; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS, INC.; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 9800 59th avenue n; plymouth, MN 55442
• MDR Report Key: 13014082
• Report Number: 2150060-2021-00032
• Device Sequence Number: 1766461
• Product Code: FEB
• UDI-Device Identifier: 00677964046674
• UDI-Public: 00677964046674
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K092387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 78400-409
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown