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

Model Number NL3000

Device Problem No Display/Image (1183)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

Upon root cause analysis by our service technician, it was found that the daily calibration had failed and the customer cleared the message and scanned anyways.It was seen that the workstation sent the scanner the notification but images were not in the browser or in the data folder on the workstation.The customer resent the study from the ui and the images were loaded.A tick calibration was completed and the raw data was checked.A daily cal and qa was completed as well.Device is operational and was returned in to service.It was found that the patient received the following dose amount:: ctdivol (mgy) : 0.623, dlp (mgy.Cm) : 31.16.

Event Description

Customer called in that she started a scout scan on ambulance, but the image did not appear.She tried again with the same result.Patient was transferred to the hospital.Customer said there was a daily calibration failed message, but she scanned anyway.

• Brand Name: CERETOM ELITE
• 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: 10216364
• MDR Text Key: 197594131
• Report Number: 3004938766-2020-00009
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172539
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL3000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1