MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION COMPACT; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9735602

Device Problems Mechanical Problem (1384); Communication or Transmission Problem (2896)

Patient Problem No Patient Involvement (2645)

Event Date 07/26/2019

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the monitor does not respond and the computer would freeze.The representative replaced the computer.The system then passed the system checkout and was found to be fully functional.Other relevant device(s) are: comp 9735602r fusion rfb loaded eu-se.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that the monitor would not respond to touch and that the computer froze and gui stopped working during a digital imaging and communications in medicine (dicom) retrieve action.This issue was identified during planned maintenance.There was no patient involved.

Manufacturer Narrative

The computer was returned to the manufacturer for analysis.Analysis found that the touch function was working but slightly off.After calibration the touch function worked as intended.It was noted the computer did have an issue moving between screens.Analysis found that the reported event was related to a computer issue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FUSION COMPACT
• Type of Device: EAR, NOSE AND THROAT 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8911842
• MDR Text Key: 155041749
• Report Number: 1723170-2019-04560
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K153247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735602
• Device Catalogue Number: 9735602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Date Manufacturer Received: 04/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2017
• 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