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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES NAVIO SIU ORTHOPEDIC STEREOTAXIC INSTRUMENT

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BLUE BELT TECHNOLOGIES NAVIO SIU ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number NPFS02000
Device Problems Circuit Failure (1089); No Apparent Adverse Event (3189)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2020
Event Type  malfunction  
Event Description
It was reported that during start up of the machine before a surgery, the screen displayed the following message with each start: "an error occurred during initialization: internal power system comm connection error. (errcode
=
4)". The equipment was swapped to continue with the procedure without delays. No other complications were reported.
 
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Brand NameNAVIO SIU
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
7000 west william cannon drive
austin
austin, TX 78735
5123913905
MDR Report Key10198017
MDR Text Key196929792
Report Number3010266064-2020-01611
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152574
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 09/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberNPFS02000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2021
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 Reuse

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