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

Model Number	NL5000
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The tablet froze transitioning from scout to scan causing the delay in the treatment.
Additional Manufacturer Narrative
The tablet froze transitioning from scout to scan.The components rebooting caused the tablet to disconnect.The solution for this issue was to replace the assembly components.After the replacement, system was tested, and no issues were noted.Several reboots, patient test scans, air calibrations, and quality assurance scans were successfully completed.No harm to patients or users.

• 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 avenue; danvers, MA 01923
• MDR Report Key: 25222031
• Report Number: 3004938766-2026-00022
• Device Sequence Number: 13210971
• Product Code: JAK
• UDI-Device Identifier: 10815411020663
• UDI-Public: (01)10815411020663(11)230512
• 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): 05/18/2026

1 Device was Involved in the Event

1 Patient 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: 04/25/2026
• Initial Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown