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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 02/25/2022
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference: case- (b)(4).
 
Event Description
It was reported that, during cori installation, the real intelligence tracking camera started beeping. The red led (device status led) on the front right of the camera was flashing red. According to the atracsys user manual, "red flashing indicates a fatal error, please contact atracsys". No case involved; therefore, there was no 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 Key13795919
MDR Text Key287347354
Report Number3010266064-2022-00193
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00885556757437
UDI-Public00885556757437
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K193120
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2022
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
Is the Reporter a Health Professional? No
Date Manufacturer Received04/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/05/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/17/2022 Patient Sequence Number: 1
Treatment
CORI ROBOTICS USA-SN (B)(4)
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