MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. BRAIN MONITOR WHT-REFURB

Model Number	10388-R
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report reference natus complaint# (b)(4).Per (b)(4) rev 87 xltek eeg psg ras.Hazard 2.1 - failure of amplifier power supply/ transformer.Effect (harm): fire - smoke inhalation, second degree burns, third degree burns.Residual risk: 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.The customer reported the power cord caught fire.There was no injury, no environmental hazard.The customer provided pictures of the affected part.The unit is end of life.The customer has been requested to return the unit for evaluation.Further investigation to be carried out.
Event or Problem Description
Power cord/plug from the ups caught fire.It has scorch marks and melting around the cord.No injuries.
Event or Problem Description
Power cord/plug from the ups caught fire.It has scorch marks and melting around the cord.No injuries.
Additional Manufacturer Narrative
Follow up report 001 reference natus complaint# (b)(4).Per (b)(4) rev 87 xltek eeg psg ras.Hazard 2.1 - failure of amplifier power supply/ transformer.Effect (harm): fire - smoke inhalation, second degree burns, third degree burns.Residual risk: 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.Investigation results: the power cord plug was evaluated by natus engineering by visual inspection; the failure appears to be related to wear and tear.The power cord plug is an older powervar design, which was enhanced in 2024 from an assemble plug to a molded plug, making the cord more robust.Root cause/probable root cause: wear and tear, the plug used in this instance was the prior assembled plug design and is beyond the 5-year warranty period provided by the manufacturer.

• Brand Name: BRAIN MONITOR WHT-REFURB
• Common Device Name: BRAIN MONITOR WHT-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: 25157951
• Report Number: 9612330-2026-00001
• Device Sequence Number: 9581988
• Product Code: OLV
• UDI-Device Identifier: 00382830002523
• UDI-Public: 00382830002523
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

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: 10388-R
• Device Catalogue Number: 10388-R
• 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: 04/14/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2026
• Supplement Report FDA Received Date: 06/15/2026
• 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