MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES TOUCHSCREEN; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 200501

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Patient Involvement (2645)

Event Date 11/14/2018

Event Type  malfunction  

Event Description

It was reported that, during cadaver lab, console didn't switch on past few attempts tried.Managed to switch on after few manipulation with cables connection.Monitor didn't receive signal, computer is running, but monitor couldn't switch on, "no video input, check cables" error.

Manufacturer Narrative

H10, h3, h6: the device was intended to be used in treatment and was not returned to the complaint unit for initial investigation.Thus visual inspection and functional evaluation could not be performed.It was reported that the console did not switch on until manipulation of the cable connections.The next time system was powered on, the monitor did not receive any signal, although the computer was running, but monitor couldn't switch on, displaying "no video input, check cables" error.There was no serial/lot number provided for dhr review so it could not be concluded if the device met the manufacturing specifications.A complaint history found similar reports, this issue will continue to be monitored.We could not confirm if there was a relationship established between the reported event and the device.Photos of the device were not provided for evaluation and the device was not returned.The reporter noted on 2/12/2019 that the system was tested and successfully used without any monitor issues, so no part would be returned and no replacement would be necessary.Since it was reported that cable connections were manipulated, it is possible that the cables were moved in such a way that affected the video input into the monitor.This could have been fixed after suggestions from the service manager to power the system down, carefully remove all of the usb connections on the rear of the cpu and touchscreen monitor, reconnect, and power up.However, since we were not present at the time of the occurrence, we cannot confirm this.The root cause was established to be undetermined after investigation.

• Brand Name: TOUCHSCREEN
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd; suite 40; plymouth, mn
• MDR Report Key: 9984171
• MDR Text Key: 188510293
• Report Number: 3010266064-2020-00906
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 200501
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1