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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM US ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES NAVIO SURGICAL SYSTEM US ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number NPFS02000
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/13/2020
Event Type  malfunction  
Event Description
It was reported that, after installing 1. Application 2. Idb 3. Language pack in navio software to a brand newly delivered system, the system was rebooted following that process and went back to calibrate the monitor. After this, the system was shut down from the navio start screen. With the system down, plugged the camera and both foot pedals in their respective spots. Then started the system and waited for the system to go through integrity tests and presented an error: "an error occurred during initialization: internal power system comm connection error. (errcode
=
400000004). " rebooted the system 2 times and the same error kept appearing. Finally, after shutting down again, unplugged the power cord and turn the system back on. With the power cord unplugged still, waited until the sn splash screen appeared and quickly plugged the power cord back in and the problem was resolved. No patient involved. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NameNAVIO SURGICAL SYSTEM US
Type of DeviceORTHOPEDIC 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 55441
Manufacturer Contact
richard confer
2828 liberty ave
suite 100
pittsburgh, PA 15222
MDR Report Key9999402
MDR Text Key189062392
Report Number3010266064-2020-01427
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNPFS02000
Device Catalogue NumberNPFS02000
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 Received08/09/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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