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

Model Number NL3000

Device Problems Smoking (1585); Device Inoperable (1663); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2016

Event Type  malfunction  

Manufacturer Narrative

The system arrived for initial review on 7/7/2016.Incoming review was held at that time.System was decontaminated and moved for root cause analysis by engineering.It was found that the base power supply was the likely cause of this failure where it exhibited a failure mode of a voltage spike that damaged the relay and main power supply.We are currently working with supplier to confirm and close the associated corrective action.

Event Description

The ct technician completed a scan in the icu and then moved the scanner away from the patient to begin a reconstruction of the patient scan.During this process, the ct technician heard a popping noise from the scanner and there was smoke.The hospital removed the scanner from the icu and moved it to their basement for evaluation, where it was found to have a power supply related failure.

• Brand Name: CERETOM NL3000
• Type of Device: CERETOM X-RAY COMPUTED TOMOGRAPHY SYSTEM
• Manufacturer (Section D): NEUROLOGICA CORPORATION; 14 electronics avenue; danvers MA 01923
• Manufacturer (Section G): NEUROLOGICA CORPORATION; 14 electronics avenue; danvers MA 01923
• Manufacturer Contact: ninad gujar ; 14 electronics avenue; danvers, MA 01923 ; 9785648500
• MDR Report Key: 5807033
• MDR Text Key: 50822615
• Report Number: 3004938766-2016-00002
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 07/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL3000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1