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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 Failure to Calibrate (2440)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/13/2020
Event Type  malfunction  
Event Description
It was reported that before a cori tka procedure, while unit had been plugged in for over an hour, a message appeared on screen ¿camera warming¿. They waited for approximately 10 min, and the message was still on screen. They re-booted the unit and the message was resolved. The patient was not in the room, so the case was not delayed and there was no injury to the patient. 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
suite 100
austin, TX 78735
5123913905
MDR Report Key10784445
MDR Text Key214550603
Report Number3010266064-2020-01955
Device Sequence Number1
Product Code OLO
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/04/2020
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2021
Was Device Evaluated by Manufacturer? No
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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