MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. Trex HD Headbox

Model Number	008043
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction

• Brand Name: Trex HD Headbox
• Common Device Name: Trex HD Headbox
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD.; 2568 bristol circle; oakville, ontarios; L6H 5 S1; CA L6H 5S1
• Manufacturer Contact: 2568 bristol circle; oakville, ontario, L6H 5-S1
• MDR Report Key: 50880713
• Report Number: 9612330-2026-00003
• Device Sequence Number: 18626692
• Product Code: GWQ
• UDI-Device Identifier: 00382830015639
• UDI-Public: 00382830015639
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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
• Operator of Device: Health Professional
• Device Model Number: 008043
• Device Catalogue Number: 008043
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown