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

Model Number	ROB10027
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a cori assisted tka surgery, the real intelligence tablet would only display 3 color tabs: red, green and blue show.The tablet was inactive and not responding to the touch elements and the large 24inch touch screen still worked but kept cutting out after 30 seconds intervals through out the procedure.To troubleshoot, it was ensured direct push insertion of the terminal contacts of the plug into the cori console, the cables were straight and not twisted or kinked during storage and in surgery and the cut out still persists.The procedure was completed, with a significant delay, with the main monitor and the nurse adjusting the plan to the surgeon desires.The patient was not harmed beyond the reported problem.
Additional Manufacturer Narrative
H3, h6: the real intelligence tablet, rob10027, sn (b)(6), intended for use in treatment was returned for evaluation.A relationship between the reported event and the device was established.Nothing was identified visually that contributed to the reported problem.A functional evaluation was performed.The reported problem was confirmed.The tablet was connected to a cori console, however only 3 color tabs would display (red, green and blue, stating: enter sleeping mode).The tablet was inactive, would not respond to touch and the led indicator flashed continuously until the notification reappeared.The console and tablet indicator weren't green, indicating the tablet was turned off.Once the power control keys in the back of the tablet were enabled, the console indicators flashed and the tablet powered on and continued operating as designed.The most likely cause of this event is a manufacturing issue, not performing task of disabling control keys affecting the operation of the tablet.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 found similar events.A historical escalation event review was completed.A review of prior escalation actions found no actions applicable to the scope of this case.The failure mode and associated risk have been anticipated within the risk file and the documented risk level is still adequate.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored 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 ; 5123913905
• MDR Report Key: 14946235
• Report Number: 3010266064-2022-00517
• Device Sequence Number: 6231015
• Product Code: OLO
• UDI-Device Identifier: 00885556757451
• UDI-Public: 00885556757451
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2022

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2022
• Supplement Date Received by Manufacturer: 09/05/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROB10024 / REAL INTELLIGENCE CORI
• Patient Sex: Unknown