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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NDI CAMERA POLARIS SPECTRA ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES NDI CAMERA POLARIS SPECTRA ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number PFSR200027
Device Problem Intermittent Communication Failure (4038)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/15/2021
Event Type  malfunction  
Event Description
It was reported that, during machine setup before a navio procedure, it was found that the camera was not getting connected. The two green leds on the polaris camera were solid as normal. Also, the usb cables were reconnected from cpu; the camera cable was also reconnected. However, the camera could not establish connection. On the hardware connect screen, it was shown that the camera was not getting connected. There was no patient involvement. No other complications were reported.
 
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Brand NameNDI CAMERA POLARIS SPECTRA
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 Key11793971
MDR Text Key249661072
Report Number3010266064-2021-00338
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00885556649541
UDI-Public885556649541
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K152574
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberPFSR200027
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 Received04/30/2021
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

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