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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CART 9734056 S7 STAFF SHRT 100-120V INTL SEE H10)

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CART 9734056 S7 STAFF SHRT 100-120V INTL SEE H10) Back to Search Results
Model Number S7
Device Problems No Display/Image (1183); Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/12/2018
Event Type  malfunction  
Manufacturer Narrative
Patient information not provided due to (b)(6) patient privacy regulations. No procode, common device name, unique device identification (udi) and/or 510k provided as this device is not released for distribution in the united states. A medtronic representative went to the site to test the equipment. It was reported that the computer of the navigation system was replaced to restore functionality.
 
Event Description
A medtronic representative reported that, while in a procedure, the navigation system monitor blacked out without prompt from the user. It was reported that restarting the navigation system temporarily restored functionality. The monitor would then lose functionality later in the procedure. The reported issue occurred four times in the procedure and restarting the navigation system would be performed until the procedure was completed. There was no reported impact on patient outcome. No additional information was provided.
 
Manufacturer Narrative
The computer was returned to the manufacturer for evaluation and after functional testing and visual/physical examination, no fault was found. The issue could not be reproduced.
 
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Brand NameCART 9734056 S7 STAFF SHRT 100-120V INTL
Type of DeviceSEE H10)
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stephanie riley
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7635267745
MDR Report Key7393190
MDR Text Key104272424
Report Number1723170-2018-01411
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
SEE H10)
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 05/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9734056
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/06/2011
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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