MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) CART 9734056 S7 STAFF SHRT 100-120V INTL; SIMILAR DEVICE: NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problems Loss of Power (1475); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Patient Involvement (2645)

Event Date 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Missing udi.Missing device manufacture date.No parts have been returned to the manufacturer for analysis.

Event Description

Medtronic received information regarding a navigation system.It was reported outside of a procedure that the screen display of the touch screen monitor had a blackout.There was no patient present.

Manufacturer Narrative

Additional information: unique device identification (udi) and device manufacture date provided.Correction: product and related fields updated to proper value.Correction: no 510(k) provided as this device is not released for distribution in the united states.

Manufacturer Narrative

The monitor was returned to the manufacturer for analysis.Analysis found that the monitor powered up with a normal display and touch function was normal.However, after warming up, the display went blank several times and then returned to a normal display.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.

• Brand Name: CART 9734056 S7 STAFF SHRT 100-120V INTL
• Type of Device: SIMILAR DEVICE: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• 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 ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7814227
• MDR Text Key: 118235836
• Report Number: 1723170-2018-04221
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S7
• Device Catalogue Number: 9734056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2018
• 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