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U.S. Department of Health and Human Services

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

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BLUE BELT TECHNOLOGIES REAL INTELLIGENCE FOOT PEDAL ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
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.
 
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Brand NameREAL INTELLIGENCE FOOT PEDAL
Type of DeviceORTHOPEDIC 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 Key11646962
MDR Text Key244849010
Report Number3010266064-2021-00272
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00885556757444
UDI-Public00885556757444
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193120
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 05/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberROB10026
Device Catalogue NumberROB10026
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 Received04/26/2021
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

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