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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (ISRAEL) POLESTAR N30 SURGICAL MRI SYSTEM SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

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MEDTRONIC NAVIGATION, INC. (ISRAEL) POLESTAR N30 SURGICAL MRI SYSTEM SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING Back to Search Results
Model Number POLESTAR
Device Problems Computer Software Problem (1112); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 02/04/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. A medtronic representative went to the site to test the equipment. It was reported that the bios settings issue was resolved. It was noted that the hard disks were replaced in the navigation system. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional.
 
Event Description
A medtronic representative reported that, while performing a planned maintenance (pm), the computer shut down without prompt from the user. It was noted that a second issue with the bios settings was found by the medtronic representative. There was no patient present when this issue was identified. No additional information was provided.
 
Manufacturer Narrative
Fda codes were updated to reflect current coding guidelines. If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePOLESTAR N30 SURGICAL MRI SYSTEM
Type of DeviceSYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (ISRAEL)
p.o. box 548
kochav yokneam bldg.
yokneam elit 20692
IS 20692
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (ISRAEL)
p.o. box 548
kochav yokneam bldg.
yokneam elit 20692
IS 20692
Manufacturer Contact
peter verhey
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key7304001
MDR Text Key101254192
Report Number1723170-2018-00928
Device Sequence Number1
Product Code LNH
Combination Product (y/n)N
PMA/PMN Number
K092308
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 05/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPOLESTAR
Device Catalogue Number9734070
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/11/2011
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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