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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE TRACKING CAMERA ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES REAL INTELLIGENCE TRACKING CAMERA ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number ROB10025
Device Problem Intermittent Communication Failure (4038)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/27/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference case (b)(4).
 
Event Description
It was reported that there was no contact between cori and real intelligence tracking camera. They tested with other camera and it gave good result. As this happened in a non-surgical environment, there was not patient involvement.
 
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Brand NameREAL INTELLIGENCE TRACKING CAMERA
Type of DeviceORTHOPEDIC 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 Key12595315
MDR Text Key277716426
Report Number3010266064-2021-00710
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K193120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROB10025
Device Catalogue NumberROB10025
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/06/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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