MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES SVCE, ISO TRANSFORMER/UPS, INTL, ROHS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 200010

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 02/24/2020

Event Type  malfunction  

Event Description

It was reported that about to set up for the demonstration, the system cart made a buzzing sound and had a burning smell inside.After it happened, the power supply was not provided.It is suspected that it was some problem with the ups system.They tried to turn it on with new fuse, but it did not work.There wasn't even a green or orange battery signal in front system display board.No patient involved.

Manufacturer Narrative

Memo for the submission added - attachment: [memo - mdr submissions.Pdf].

Manufacturer Narrative

The device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional evaluation could not be performed.A complaint history review found similar report, this issue will continue to be monitored.The dhr could not be reviewed and it was not confirmed if the product met manufacturing specifications.A relationship, if any, between the subject device and the reported event could not be determined.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.A factor that could have contributed to the reported issue is if the ups was not fully charged or there was a ups battery issue.Additional information on d10 and h3.

• Brand Name: SVCE, ISO TRANSFORMER/UPS, INTL, ROHS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• MDR Report Key: 9999758
• MDR Text Key: 188984203
• Report Number: 3010266064-2020-01515
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 200010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1