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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.
 
Manufacturer Narrative
H3, h6: the real intelligence tracking camera, part number rob10025, s/n (b)(6), intended for use in treatment was not returned for evaluation.Thus, a visual and functional evaluation could not be performed, however, a relationship between the reported event and the device was confirmed, as log files provided by the customer confirmed the complaint.An assessment of log files confirmed that the camera warming message was present.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.The complaint was confirmed; however, no problem was detected as the temperature threshold that triggers camera warming notification is within the designed parameters of the device.Although no further containment or corrective action is recommended or required at this time, all complaints are monitored and trended through post market surveillance activities.If the product associated with this event is returned or provided at a future date, this evaluation will be reopened for investigation.
 
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Brand Name
REAL INTELLIGENCE TRACKING CAMERA
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth MN 55441
MDR Report Key10784445
MDR Text Key214550603
Report Number3010266064-2020-01955
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00885556757437
UDI-Public00885556757437
Combination Product (y/n)N
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 10/15/2021
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Model NumberROB10025
Device Catalogue NumberROB10025
Was Device Available for Evaluation? No
Date Manufacturer Received10/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ROB20000/CORI ROBOTICS USA.
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