MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® NEXUS - CONSOLE; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	1894510
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Oversedation (1990)
Date of Event	03/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis found that the unit came in with no power.Fuse box was disconnected and loose.Reconnected cable.The unit was cleaned, repaired, and tested to manufacturing specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider reported that the device had blown fuses during the procedure.The patient was under anesthesia when the issue occurred.They had to roll them out after the equipment broke down.The case was canceled and rescheduled for a later date.

• Brand Name: XPS® NEXUS - CONSOLE
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 9075232
• Report Number: 1045254-2019-00455
• Device Sequence Number: 2976879
• Product Code: HBE
• UDI-Device Identifier: 00643169434134
• UDI-Public: 00643169434134
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1894510
• Device Catalogue Number: 1894510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other