MAUDE Adverse Event Report: SAMSUNG HME AMERICA, INC. NL5000; COMPUTED TOMOGRAPHY X-RAY SYSTEM

Model Number	NL5000
Date of Event	05/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The scanner was stuck in the icu hallway causing delay in the treatment.
Additional Manufacturer Narrative
The scanner was stuck due to a defective battery.The corrective measure for the ticket was to replace it with the new battery.Completed several test scans, air calibrations, and quality assurance scans with no problems noted.No harm to the patient or user.

• Brand Name: NL5000
• Common Device Name: COMPUTED TOMOGRAPHY X-RAY SYSTEM
• Manufacturer (Section D): SAMSUNG HME AMERICA, INC.; 14 electronics ave; danvers MA 01923
• Manufacturer (Section G): SAMSUNG HME AMERICA, INC.; 14 electronics ave; danvers MA 01923
• Manufacturer Contact: ninad gujar ; 14 electronics ave; danvers, MA 01923
• MDR Report Key: 25386905
• Report Number: 3004938766-2026-00027
• Device Sequence Number: 21517275
• Product Code: JAK
• UDI-Device Identifier: 10815411020335
• UDI-Public: (01)10815411020335(11)180925
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K202526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 06/02/2026

1 Device was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: NL5000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse