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

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.

• Brand Name: UPS US 200029
• Type of Device: ORTHOPEDIC 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 Key: 9994207
• MDR Text Key: 188809886
• Report Number: 3010266064-2020-01147
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• 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 Received: 04/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 200029
• 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 Received: 07/10/2020
• 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