MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. TREX HD HEADBOX-REFURB

Model Number	008043R
Medical Device Problem Codes	Failure to Back-Up (1047); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report reference natus complaint# (b)(4).Related report - uf/importer report # 0700220000-2026-8184 received 27 may 2026.Per doc-010378 rev 87 xltek eeg psg ras hazard 5.17 - amplifier channel malfunctions, such as due to damage, hardware failure, firmware failure, aging, etc.Effect (harm): delayed diagnosis - with no clinical effects.Residual risk: low the hazards identified have rba rating of negligible and are deemed broadly acceptable.These risks have been reviewed to determine if any further control measures may be implemented so as to further reduce the risk as far as possible.Risk outweighed by benefit of use of device.No related capas.Install date of device:18-nov-25.Replacement part number description:trex hd headbox-refurb sn 008043o4034 was shipped to the customer.The affected part was returned.As per depot repair notes: reported problem confirmed loose usb connection, damaged battery door.Replaced usb port and battery door.Cleaned and tested, passed all functional tests.The failure was confirmed.Investigation result code: neuro sbu|connector damaged.
Event or Problem Description
Trex hd headbox-refurb - 24-hour ambulatory eeg [electroencephalogram] test returned for disconnect and only 3 minutes of data able to be uploaded.It was confirmed the box malfunctioned and only 3 of the 24 hours of data recorded.Box taken out of service and bmdi [bedside medical device interface] ticket placed.This is the second incident in 2 weeks in which an ambulatory eeg patient returned with equipment issues resulting is data not acquired.No injuries.

• Brand Name: TREX HD HEADBOX-REFURB
• Common Device Name: TREX HD HEADBOX-REFURB
• 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: 25426647
• Report Number: 9612330-2026-00002
• Device Sequence Number: 9929442
• Product Code: GWQ
• UDI-Device Identifier: 00382830015639
• UDI-Public: 00382830015639
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/08/2026

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: 008043R
• Device Catalogue Number: 008043R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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