• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BLUE BELT TECHNOLOGIES CAMERA, POLARIS SPECTRA ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 200027
Device Problem Defective Component (2292)
Patient Problem No Patient Involvement (2645)
Event Date 04/18/2019
Event Type  malfunction  
Event Description
It was reported that the camera bump sensor turned on. There was no patient involved. The investigation found camera was showing the error "camera infrared lamp is not working properly" which is related to an illuminator hardware fault. The bump sensor was not on, it was the orange led indicator.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCAMERA, POLARIS SPECTRA
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
Manufacturer (Section G)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
Manufacturer Contact
richard confer
2828 liberty ave
suite 100
pittsburgh, pa 
6833844
MDR Report Key9993948
MDR Text Key188854743
Report Number3010266064-2020-00944
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number200027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-