MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES REAL INTELLIGENCE FOOT PEDAL ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number ROB10026

Device Problem Intermittent Communication Failure (4038)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2021

Event Type  malfunction  

Event Description

It was reported that, during preventative maintenance of cori, they entered an existing test case and the pedal would not connect. Therefore, they unplugged and re-plugged the pedal, but the connection light would not light up. So, they powered down system, restarted and created new test case. The pedal connected at connection screen, and they advanced to bur options, but a pedal disconnection pop-up. They unplugged and re-plugged to clear it, but it took multiple tries. There was no patient involvement. No other complications were reported.

• Brand Name: REAL INTELLIGENCE FOOT PEDAL
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: holly topping ; 2905 northwest blvd ste 40; plymouth, MN 55441 ; 5123913905
• MDR Report Key: 11646962
• MDR Text Key: 244849010
• Report Number: 3010266064-2021-00272
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00885556757444
• UDI-Public: 00885556757444
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193120
• 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: 05/05/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: ROB10026
• Device Catalogue Number: ROB10026
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage