MAUDE Adverse Event Report: NEUROLOGICA CORP NL4000; BODYTOM ELITE

Model Number NL4000

Device Problem No Display/Image (1183)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 04/14/2023

Event Type  malfunction  

Event Description

It was reported that upon starting a scan, the system moved but did not acquire images.An error message then presented on the user interface.

Manufacturer Narrative

Neurologica field service representative assessed, rebooted and calibrated the system.A test scan was completed to verfiy the operation of the device and no issues were found.Internally, the scanner's computer logs were assessed and it was determined to be a minor software error found.There is no concern at this time to investigate further.As the patient may have been re-scanned and potentially received additional unintended radiation, this report is being filed out of caution.At this time, no additional customer compaints related to this incident has been received.If additional infrmation is obtained, a follow up report will be filed.

• Brand Name: NL4000
• Type of Device: BODYTOM ELITE
• Manufacturer (Section D): NEUROLOGICA CORP; 14 electronics ave; danvers MA 01923
• Manufacturer (Section G): NEUROLOGICA CORPORATION; 14 electronics avenue; danvers MA 01923
• Manufacturer Contact: ninad gujar ; 14 electronics avenue; danvers, MA 01923 ; 9785648632
• MDR Report Key: 16947747
• MDR Text Key: 316243790
• Report Number: 3004938766-2023-00008
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170238
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NL4000
• Device Catalogue Number: 0-NL4000-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2021
• 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