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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 Known Impact Or Consequence To Patient (2692)
Event Date 02/11/2019
Event Type  malfunction  
Event Description
It was reported that there were two separate errors, but we think both occurred because the machine has gone unused since (b)(6) 2018. The first problem related to the internal battery of the cpu. Because it had died, i had to reset the bios and date settings before booting the system. Upon solving that issue, i got errcode
=
2000000000000 ups back-up batter is not working properly. The led indicator on the far right, in the front panel of the navio cart was red. When i talked to (b)(6), he said i just had to wait for it to get some charge. However, after multiple reboots and about 20 minutes of charging, the led indicator remained red and the error would show up when the system booted. Case had to be cancelled.
 
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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 Key9994207
MDR Text Key188809886
Report Number3010266064-2020-01147
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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