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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 11/13/2020
Event Type  malfunction  
Event Description
It was reported that, during a cori installment, the camera's led indicator was flashing red, indicating a fatal error. The system was unable to detect the camera even after they verified all the connections. The system was not able to detect the camera, so they were unable to complete camera diagnostics. No patient was involved. No other complications were reported.
 
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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 Key10935453
MDR Text Key219192890
Report Number3010266064-2020-02083
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00885556757437
UDI-Public00885556757437
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2020
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 Manufacturer11/24/2020
Is the Reporter a Health Professional? No
Date Manufacturer Received11/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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