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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION® ENT NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC FUSION® ENT NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9733560
Device Problems Environmental Compatibility Problem (2929); Audible Prompt/Feedback Problem (4020); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/07/2021
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Concomitant medical products: product id: 9735368, serial/lot #: (b)(4), udi#: (b)(4). The manufacturer representative went to the site to test the navigation system. The computer did not boot correctly. The computer was replaced. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system. It was reported outside of a procedure that the computer does not boot anymore. When powering on the system the fans of the computer turn on but the computer does not boot into the operating system. In addition, there was no sound playing indicating that the computer was booting. After a few seconds it seemed that the computer restarted since the fans stopped for some time, just to restart again. This process loops until the station was disconnected from power. The screen had power and was working. No patient was present at the time of the event. Additional information was received stating that the computer never really ¿booted¿. There was no bios or operating system messages visible. Only the fan of the computer indicated that the computer turned on. The ¿reboot¿ (turn off of the fan and turning on again) happened on its own.
 
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Brand NameFUSION® ENT NAVIGATION SYSTEM
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key12528289
MDR Text Key273340480
Report Number1723170-2021-02367
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K001284
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733560
Device Catalogue Number9733560
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2015
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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