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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES UPS US 200029 ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES UPS US 200029 ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 200029
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Patient Involvement (2645)
Event Date 01/14/2019
Event Type  malfunction  
Event Description
It was reported that sales rep started up the cart as normal and was able to input information and begin a case. About 15 minutes after beginning i got an error message stating ups communication failure. Only option was to dismiss, which in turn forced me to exit the case and return to the case input screen. Sales tried resuming the case but immediately got the same error message. Sales rep completely shut down the machine and restarted. The same thing happened after every attempt. Every time sales rep restarted, the error message came up sooner than the time before. He checked to make sure everything was plugged in securely in the back of the machine and all cords were connected securely. No during surgery.
 
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Brand NameUPS US 200029
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 Key9994210
MDR Text Key188815696
Report Number3010266064-2020-01145
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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 Received04/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number200029
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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