MAUDE Adverse Event Report: NEUROLOGICA CORPORATION CERETOM; CERETOM NL3000 COMPUTED TOMOGRAPHY SYSTEM

Model Number	NL3000
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Radiation Exposure, Unintended (3164)
Date of Event	12/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer was able to duplicate the issue upon re-test.A software anomaly was uncovered with new software version upgrade (06.04).The two noted patients were scanned and received the following dose accumulation of 182.72mgy (or ctdi.Vol) and 194.51mgy (or ctdi.Vol).The system was reconfigured backed down to 06.03 and issue was resolved and system calibration was done successfully.The suspect software code has been resolved and is a candidate for effectivity on a new version of software to be released as 06.04.01, which is under beta testing at this time.No population injury was incurred as a result of this issue.The software fix once effective after verification and validation testing will resolve this issue.The dose accrual did not exceed the 1 gy threshold neurologica has in place by design.
Event or Problem Description
Customer called to report that during multiple scans, the system initially would shoot x-ray as required, but then moved the incorrect distance on its own and then started to emit x-ray again.

• Brand Name: CERETOM
• Common Device Name: CERETOM NL3000 COMPUTED TOMOGRAPHY SYSTEM
• Manufacturer (Section D): NEUROLOGICA CORPORATION; 14 electronics ave; danvers MA 01923
• MDR Report Key: 7233983
• Report Number: 3004938766-2017-00013
• Device Sequence Number: 16507831
• Product Code: JAK
• UDI-Device Identifier: 10815411020007
• UDI-Public: 10815411020007
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Radiologic Technologist
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 01/24/2018

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: Radiologic Technologist
• Device Model Number: NL3000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 02/01/2018
• 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