MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. NATUS PHOTIC STIM KIT

Model Number	003555
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref to natus complaint # (b)(4).Install date of device : sep/30/2022 further investigation to be carried out.
Event or Problem Description
Natus photic stim kit - eeg tech was adjusting light when her skin got pinched between the two arms of equipment.30 minutes in the ed getting finger stitched up.
Event or Problem Description
Natus photic stim kit - eeg tech was adjusting light when her skin got pinched between the two arms of equipment.30 minutes in the ed getting finger stitched up.
Additional Manufacturer Narrative
Follow up report 001 ref to natus complaint # (b)(4).Ref.Xltek photic stimulator on a roll stand.Ref.10440 serial number (b)(6).Per (b)(4) rev 78 eeg/psg risk analysis: hazard 6.1 - sharp corner, edges or pinch points.Effect (harm): bruise / contusion or abrasion rba rating: low.The hazards identified have been evaluated and found to be in compliance with a known standard.As noted in qms-000018 (risk management system procedure), 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.As per the customers response, the customer will not return the affected device for evaluation.Because the customer is not able to return the device, no further investigation can be made.Complaint will be included in trending data for further review.

• Brand Name: NATUS PHOTIC STIM KIT
• Common Device Name: NATUS PHOTIC STIM KIT
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD.; 2568 bristol circle; oakville, ontario, ca, L6H 5 S1; CA L6H 5S1
• Manufacturer Contact: gráinne walsh ; 2568 bristol circle; oakville, ontario, ca, L6H 5-S1 ; CA L6H 5S1
• MDR Report Key: 21177743
• Report Number: 9612330-2025-00001
• Device Sequence Number: 8630674
• Product Code: GWE
• UDI-Device Identifier: 00382830015790
• UDI-Public: 00382830015790
• 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): 05/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 003555
• Device Catalogue Number: 003555
• Device Lot Number: 10440R9574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 05/12/2025
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown