MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES OUS UPS 1ST GEN 200010; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 200010

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/23/2018

Event Type  malfunction  

Event Description

It was reported that during a case a brand new installed ups, it is reporting a known false overload condition.The ups also sounds a beep at regular intervals as a result of the condition.Silenced the audible tone from the ups.

Manufacturer Narrative

H3, h6: the ups was intended for use in treatment, ups reported a false overload condition and beeped at regular intervals as a result of the condition.The device was returned for evaluation.Dhr review found that no conditions which could contribute to the reported event were identified.This information is reasonably suggesting that the device met the specifications at the date when it was released to the distribution.A complaint history found similar reports, this issue will continue to be monitored.We could confirm there was a relationship established between the reported event and the device.The device was returned and investigated for initial investigation.Visual and functional inspection confirmed that this is a known issue with this model of the ups to show false overload errors.This has been resolved in a software update so that the system does not preclude the user from performing a case when this issue occurs.The reported been was likely due to the ups not being plugged in to mitigate future occurrences.Based on the investigation, it is likely that the event occurred due to the reported failure.The malfunction is most probably due to an electrical component failure.

• Brand Name: OUS UPS 1ST GEN 200010
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth, mn
• MDR Report Key: 9998985
• MDR Text Key: 189314344
• Report Number: 3010266064-2020-00932
• 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
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was 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: Health Professional
• Device Catalogue Number: 200010
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1