MAUDE Adverse Event Report: NEUROLOGICA CORPORATION OMNITOM; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number	NL5000
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event was reported to the fda ((b)(4)) by the user facility to the fda and the manufacturer is reporting this mdr with additional context.There was no injury associated with this issue.Upon root cause analysis by our service technician, the ct had a blown fuse on the pcd, requiring a service representative on the premises to replace it.System passed daily calibration, qa check, pulled the worklist and sent images to pacs.System was driving normally in storage closet.Customer acknowledged later that a lift was actually available at their premises to move the ct manually.Since the customer was not satisfied with the ct, neurologica decided to replace with another unit and the affected unit was returned to neurologica for replacement.
Event or Problem Description
The omnitom ct system was moved to nicu for an ordered ct.The scanner stopped moving and the screen said 'locked scanner'.The scan was not able to be performed and the machine was blocking the patient room entrance.The ct scanner was moved out of the way as it was blocking the patient's doorway.After knowing that the scan was not going to be completed, the patient was returned to the normal bed positioning.Customer reported difficulty communicating with mfg.Customer service at the time and unsuccessful troubleshooting.No user or patient injury reported.

• Brand Name: OMNITOM
• Common Device Name: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): NEUROLOGICA CORPORATION; 14 electronics avenue; danvers MA 01923
• MDR Report Key: 8828078
• Report Number: 3004938766-2019-00004
• Device Sequence Number: 2510594
• Product Code: JAK
• UDI-Device Identifier: 10815411020335
• UDI-Public: 011081541102033511190130
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K171183
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/25/2019

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: NL5000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR