MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. EMU40EX BREAKOUT BOX-REFURB

Model Number	006562R
Medical Device Problem Codes	Circuit Failure (1089); Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report reference natus complaint#: (b)(4).Per (b)(4) rev 86 xltek eeg / psg risk analysis spreadsheet (ras).Hazard 2.9 - internal short circuit.Efftect (harm) - fire - smoke inhalation, second degree burns, third degree burns.Severity - medium.The hazards identified have been evaluated and found to be in compliance with a known standard.As noted in qms-000018, hazards that have been evaluated and found to be in compliance with known standards can be presumed to be consistent with an acceptable level of risk, yielding an acceptable risk / benefit to the patient or user.Risk outweighed by benefit of use of device.Install date: on (b)(6) 2024.
Event or Problem Description
Part: 006562r, emu40ex breakout box-refurb - smoke was emitted from two base units in connection with this breakout box.No medical intervention required.The procedure was video-eeg.The smoke and odor appeared immediately after starting the registration.
Additional Manufacturer Narrative
Follow up report 001 reference natus complaint# (b)(4).On 24 sept 2025 - the affected device was received by natus ireland, and will be shipped to the middleton site for evaluation.
Event or Problem Description
Part 006562r, emu40ex breakout box-refurb - smoke was emitted from two base units in connection with this breakout box.No medical intervention required.The procedure was video-eeg.The smoke and odor appeared immediately after starting the registration.
Event or Problem Description
Part 006562r, emu40ex breakout box-refurb - smoke was emitted from two base units in connection with this breakout box.No medical intervention required.The procedure was video-eeg.The smoke and odor appeared immediately after starting the registration.
Additional Manufacturer Narrative
Follow up report 002 reference natus complaint# (b)(4).10-oct-2025 device received in middleton and delivered to engineering for evaluation.20-oct-2025 qa followed up with engineering.Investigation results not yet available.
Event or Problem Description
Part: 006562r, emu40ex breakout box-refurb - smoke was emitted from two base units in connection with this breakout box.No medical intervention required.The procedure was video-eeg.The smoke and odor appeared immediately after starting the registration.
Additional Manufacturer Narrative
Follow up report 003 reference natus complaint#: (b)(4).Per doc-010378 rev 86 xltek eeg / psg risk analysis spreadsheet (ras).Hazard 2.9 - internal short circuit.Efftect (harm) - fire - smoke inhalation, second degree burns, third degree burns.Severity - medium.The hazards identified have been evaluated and found to be in compliance with a known standard.As noted in qms-000018, hazards that have been evaluated and found to be in compliance with known standards can be presumed to be consistent with an acceptable level of risk, yielding an acceptable risk / benefit to the patient or user.Risk outweighed by benefit of use of device.No related capas.Investigation results: the device was opened and evaluated to see if there was any sign of failed or burnt components.There were no failed or burnt components observed.Functional testing was conducted on the device with no failures observed.Root cause/probable root cause: n/a, no failures observed.Recommended actions: device is aged and will be scrapped.No further actions.

• Brand Name: EMU40EX BREAKOUT BOX-REFURB
• Common Device Name: EMU40EX BREAKOUT BOX-REFURB
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD.; 2568 bristol circle; oakville, ontarios; L6H 5 S1; CA L6H 5S1
• Manufacturer Contact: gráinne walsh ; 2568 bristol circle; oakville, ontario, L6H 5-S1 ; CA L6H 5S1
• MDR Report Key: 22930282
• Report Number: 9612330-2025-00019
• Device Sequence Number: 10223340
• Product Code: GWQ
• UDI-Device Identifier: 00382830011297
• UDI-Public: 00382830011297
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K163163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/11/2025

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: 006562R
• Device Catalogue Number: 006562R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 09/29/2025; 10/24/2025; 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown