MAUDE Adverse Event Report: MEDIVATORS INC. DSD EDGE; ACCESSORIES, CLEANING, ENDOSCOPE

Device Problems Failure to Cycle (1142); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 09/11/2017

Event Type  malfunction  

Event Description

Per the reporter, repeated "bas sen err" message given when trying to clean scopes in the dsd edge machine just purchased a few months ago.Error started with just one side of the basin, but then switched to both sides.When they try to resume the cycle, it aborts the cycle.They restart the whole cycle and it completes the cycle.It has been reported that this was happening frequently.

• Brand Name: DSD EDGE
• Type of Device: ACCESSORIES, CLEANING, ENDOSCOPE
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 6922155
• MDR Text Key: 88447899
• Report Number: 6922155
• Device Sequence Number: 1
• Product Code: FEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/15/2017
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1