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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES CAMERA, POLARIS SPECTRA; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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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.
 
Manufacturer Narrative
H10 h3, h6: the device was intended for use in treatment and it was noticed the camera bump sensor turned on.Dhr review found that no conditions which could contribute to the reported event were identified.This information is reasonably suggesting that the device met the specifications at the date when it was released to the distribution.A complaint history found similar reports, this issue will continue to be monitored.The investigation confirmed there was a relationship established between the reported event and the device.The device was returned and was connected to the system and there was an error saying that the "camera infrared lamp is not working properly".The part was returned to the oem for evaluation.The malfunction is most probably due to supplier / raw material fault.
 
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Brand Name
CAMERA, POLARIS SPECTRA
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
MDR Report Key9993948
MDR Text Key188854743
Report Number3010266064-2020-00944
Device Sequence Number1
Product Code OLO
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,foreig
Type of Report Initial,Followup
Report Date 04/23/2020
1 Device was Involved in the Event
1 Patient was 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
Date Manufacturer Received06/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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