MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE CORI; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10024

Device Problem Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Date 08/05/2020

Event Type  malfunction  

Event Description

It was reported that, upon assembly/installment and checking all possible power connections, there was no power to the small cori tablet.The inside lights will turn on but no visible illumination on the small tablet where the power button should appear.Trouble shooting and checking all internal connections was done, but it was not resolved.It was concluded that there is a connection issue deep in the electronic panel of the console.No patient was involved.No other complications were reported.

Manufacturer Narrative

The cori console intended for use in treatment was returned for evaluation.Nothing was identified visually that contributed to the reported complaint.A functional evaluation was performed.The reported problem was confirmed.The console screen would not power on.An evaluation was completed by the engineering team.The latch holding the ribbon cable in the pmb connector was found in the open position.I fully inserted the ribbon cable into the connector and closed the latch; the fpui functioned normally after that.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/ confirmed complaints associated with the part with the failure modes 'failure to power up ' identified no similar events.The most likely cause of this event was the ribbon cable was not properly locked down and was not making connection so the tablet would not power up.Based on the investigation, no further containment or corrective action is recommended or required at this time.Internal complaint reference number: case-2020-00014358-2.

• Brand Name: REAL INTELLIGENCE CORI
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 10480800
• MDR Text Key: 205261401
• Report Number: 3010266064-2020-01742
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757420
• UDI-Public: 00885556757420
• 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: 03/31/2021

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 Operator: Health Professional
• Device Model Number: ROB10024
• Device Catalogue Number: ROB10024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 03/26/2021
• Supplement Dates FDA Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: REAL INTELLIGENCE 24 IN. TOUCH SCREEN; REAL INTELLIGENCE 24 IN. TOUCH SCREEN