MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC CART 9734056 S7 STAFF SHRT 100-120V INTL

Model Number 9734056

Device Problem Audible Prompt/Feedback Problem (4020)

Patient Problem No Patient Involvement (2645)

Event Date 10/17/2018

Event Type  malfunction  

Manufacturer Narrative

No procode, common device name 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.Testing revealed that the monitor was flickering.The monitor and external cable were replaced, and the issue resolved.The system then passed the system checkout and was found to be fully functional.The monitor was returned to the manufacturer for analysis.Analysis found that the reported issue could not be duplicated.The returned monitor had scratches on the display but was otherwise functional.When connected to a known good system, the monitor displayed a good image with none of the reported flickering.No problem was found.The cable was returned to the manufacturer for analysis.Analysis found that reported issue could be duplicated.A continuity test of the returned cable revealed an open from pin 10 of the h26 connector to pin 16 of the fischer connector.Analysis found that the reported event was related to an electrical issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.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 that a noise was noted with the monitor.A "boo" sound was also heard.When touching the cable, the issue of the sound was resolved, but the noise remained the same.There was no patient present when this issue was identified.The external cable was returned for analysis and an open was found.

• Brand Name: CART 9734056 S7 STAFF SHRT 100-120V INTL
• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8325610
• MDR Text Key: 136325128
• Report Number: 1723170-2019-00604
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2018
• Device Model Number: 9734056
• Device Catalogue Number: 9734056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1