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

Model Number NL5000

Device Problem Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Date 02/24/2020

Event Type  malfunction  

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, it was found that a wire had come off.The service engineer replaced the electrical components and the ct system is back up and fully operational.The ct system passed the daily calibration and qa check.

Event Description

The omnitom computed tomography (ct) system did not power up.

• Brand Name: OMNITOM
• Type of Device: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): NEUROLOGICA CORPORATION; 14 electronics avenue; danvers, ma
• Manufacturer (Section G): NEUROLOGICA CORPORATION; 14 electronics avenue; danvers, ma
• Manufacturer Contact: ninad gujar ; 14 electronics avenue; danvers, ma ; 5648632
• MDR Report Key: 10216322
• MDR Text Key: 197652430
• Report Number: 3004938766-2020-00007
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL5000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1