MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES ASSY, CPU, COMPUTER CART, NAVIO; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number PFSR220001

Device Problem Power Problem (3010)

Patient Problem Injury (2348)

Event Date 08/12/2016

Event Type  malfunction  

Event Description

It was reported that during a procedure, when advancing from the hip center screen, the screen showed some pixilation and checkered color patterns.After restarting the machine, the problem persisted.All monitor connections were double checked, but the behavior continued and the screen locked up and wouldn't advance by touch (pedals were not tried).The system was restarted multiple times with no success.The procedure was converted to manual.The investigation found the problem was the cpu, it had a defective/damaged graphics card.

Manufacturer Narrative

The device was used in treatment and it was reported that the monitor was displaying a pixelated view.Dhr review found that no conditions which could contribute to the reported event were identified.This information is reasonably suggesting that the device met the specifications at the date when it was released to the distribution.A complaint history found similar reports, this issue will continue to be monitored.The surgical system user's manual released at the time of the complaint provides instructions for troubleshooting computer issues.This is an identified failure mode within the risk assessment.We could confirm there was a relationship established between the reported event and the device.The device was returned for investigation.The returned monitor and cpu were tested and the complaint was confirmed.When the monitor with a known good cpu was tested, no problem was found.The cpu was tested with another known good monitor and the problem persisted.Swapped the graphics card on the cpu to rule out a graphics card issue and tested with the same "known good" monitor.The error did not present itself when attempted with a "known good" graphics card.The root cause of the error is most likely a defective/damaged graphics card.The root cause was supplier / raw material fault.A corrective action was opened for this issue.Per complaint details, the device malfunctioned during use and the navio was abandoned for manual instrumentation.Based on the information provided the impact beyond the reported modified procedure/conversion to manual could not be determined.No further medical assessment is warranted at this time.

• Brand Name: ASSY, CPU, COMPUTER CART, NAVIO
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9989223
• MDR Text Key: 188648681
• Report Number: 3010266064-2020-00277
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PFSR220001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• Date Manufacturer Received: 08/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR