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

Model Number S7

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information not provided due to japanese 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 site to test the equipment.Representative reported that when the external cable of the surgeon monitor was plugged into the staff cart, the monitor turned on for two seconds but turned off after that.The monitor was replaced.A system checkout was performed after replacing the part.The hardware, software, and "instrunal.Ments" passed the system checkout.The system was found to be fully functional.The suspect monitor has been not received by manufacturer for evaluation.

Event Description

A medtronic representative reported that during a cranial based procedure the surgeon monitor of the navigation system could not be turned on.The procedure was completed with the use of navigation.There was no delay to the procedure.No impact on patient outcome.

Manufacturer Narrative

The suspect monitor was returned to the manufacturer for evaluation.Functional testing, when connected to a known operational navigation system, found that the monitor would lose functionality just after powering on.The display was reported to be intermittent when re-inserting the cable.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

• Brand Name: CART 9734056 S7 STAFF SHRT 100-120V INTL
• Type of Device: SEE 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: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 6831543
• MDR Text Key: 84398300
• Report Number: 1723170-2017-03540
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: SEE H10)
• Number of Events Reported: 1
• 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: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9734056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/02/2017
• Initial Date FDA Received: 08/30/2017
• Supplement Dates Manufacturer Received: 09/12/2017
• Supplement Dates FDA Received: 10/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2012
• 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