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

Model Number	ROB10027
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, when powered on the console and plugged in the real intelligence tablet, the screen did not fully come on.The system was restarted and it did come on, but trying to calibrate showed a "communication error" with each handpiece.The next day a new tablet was available and was able to get the tablet to work with the existing console and had no issues with handpiece calibration.As this was noticed in a non-surgical environment, there was not any patient involved.
Additional Manufacturer Narrative
H3, h6: the real intelligence tablet, part number rob10027, serial number (b)(6), used for treatment was not returned for evaluation.A relationship between the reported event and the device could not be established.A complaint history review for similar reported/confirmed complaints has identified prior events.A review of manufacturing records indicate the device met all specifications upon release into distribution.The failure mode and associated risk have been anticipated within the risk file.The risk level is still adequate.Although the reported problem was not confirmed through a visual or functional evaluation, factors contributing to the reported symptom may have been associated with emi interference causing tablet to flicker.Based on the investigation, the need for a corrective action is not recommended or required at this time.Should any additional information be received the complaint will be reopened.The failure mode will continue to be closely monitored through complaint investigation and trended through post market surveillance activities.

• Brand Name: REAL INTELLIGENCE TABLET
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15434367
• Report Number: 3010266064-2022-00606
• Device Sequence Number: 6020939
• Product Code: OLO
• UDI-Device Identifier: 00885556757451
• UDI-Public: 00885556757451
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

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
• Operator of Device: Health Professional
• Device Model Number: ROB10027
• Device Catalogue Number: ROB10027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 10/18/2022
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROB10024, LOT#:SN000250
• Patient Sex: Unknown