MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM-ECLIPSE® NOTEBOOK COMPUTER; STIMULATOR, ELECTRICAL, EVOKED RESPONSE

Model Number	NCCPU
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report. a follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The health care provider (hcp) reported that the computer was not working properly.There was no known patient impact reported.
Additional Manufacturer Narrative
Analysis found that the unit has an old software present.The unit has been sent to manufacturer for software upgrade and testing.The software was freezing upon exiting sd mode.Reinstalling software would not solve the issue.The hard drive was reimaged.The unit was then tested and passed manufacturing specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
There was no patient impact.

• Brand Name: NIM-ECLIPSE® NOTEBOOK COMPUTER
• Common Device Name: STIMULATOR, ELECTRICAL, EVOKED RESPONSE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8518223
• Report Number: 1045254-2019-00193
• Device Sequence Number: 1612813
• Product Code: GWF
• UDI-Device Identifier: 00613994910677
• UDI-Public: 00613994910677
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• PMA/510(K) Number: K061639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2019

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
• Operator of Device: Health Professional
• Device Model Number: NCCPU
• Device Catalogue Number: NCCPU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1