MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE 24 IN. TOUCH SCREEN; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	ROB10003
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during assembly of cori, the 24 inch touchscreen monitor will turn on, yet nothing will appear on the screen.When they attempted to press "menu", nothing happened, and the monitor turns off on it¿s own.They ensured everything was plugged in appropriately (the tablet works and portrays what should be on the monitor screen), but they don't see anything on the monitor.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
H3, h6: the cori touchscreen, p/n rob10003, (b)(6), intended for used in treatment, was returned for evaluation.A relationship between the reported event and the device was not establish.The touchscreen pass all testing, no malfunction was observe.Touchscreen operated as design.In addition, a functional evaluation was performed on the part beyond the reported complaint.No additional functional non-conformances were identified.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 has identified prior events.Although the reported problem was not confirmed, factor that may have contributed to the reported symptom may have been associated with internment electrical failure.A historical capa, nc, hhe/pra, field action 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 that the documented risk level is still adequate.No further containment or corrective action is recommended or required at this time, all complaints are monitored through complaint investigation and post market surveillance activities.

• Brand Name: REAL INTELLIGENCE 24 IN. TOUCH SCREEN
• 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: 11741223
• Report Number: 3010266064-2021-00319
• Device Sequence Number: 16933412
• Product Code: OLO
• UDI-Device Identifier: 00885556756256
• UDI-Public: 00885556756256
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K193120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

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: ROB10003
• Device Catalogue Number: ROB10003
• Device Lot Number: GMO312F040003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2021
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 02/02/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown