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

Model Number NL3000

Device Problems Smoking (1585); Device Inoperable (1663)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 07/17/2016

Event Type  malfunction  

Manufacturer Narrative

Neurological personnel were onsite to investigate the issue and a further investigation of the reported event is in progress to determine the cause of the issue.The leading suspicion for the failure was the power distribution board wherein a short of unknown origin (at this time) caused said board to smoke.Supplier involvement of the scanner drive system will be utilized to support the review.

Event Description

It was reported that the scanner drive system (sds), an accessory used to facilitate transporting ceretom, sparked and smoked.There was no ac power applied to the system when the failure occurred.The sds was not connected to the ceretom scanner.

• 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: 5858234
• MDR Text Key: 51850366
• Report Number: 3004938766-2016-00003
• 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: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• 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: 07/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/28/2015
• 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