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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES SIU; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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BLUE BELT TECHNOLOGIES SIU; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 220025
Device Problem Defective Component (2292)
Patient Problem No Patient Involvement (2645)
Event Date 04/08/2019
Event Type  malfunction  
Event Description
It was reported that new siu module from stock is not working.No patient involved.
 
Manufacturer Narrative
H10 h3, h6: the device, intended for use during treatment, was returned for investigation.The initial functional inspection of the returned siu found that the device received a 40000000000-error message when powered on.This was indicative of fuse damage.The dhr was reviewed for the device at the time of manufacturing and passed all tests.Therefore, the reported product met manufacturing specifications prior to be released for distribution.A complaint history review found similar similar reports of the issue.The relationship of the device and the reported event has been established.The error message is caused by a blown fuse in the siu.The root cause of the reported event was due to electrical component failure.
 
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Brand Name
SIU
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
BLUE BELT TECHNOLOGIES
2905 northwest blvd ste 40
plymouth, mn
MDR Report Key9998264
MDR Text Key189767723
Report Number3010266064-2020-01070
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 04/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number220025
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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