MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED EMU40EX BREAKOUT BOX-REFURB

Model Number	006562R
Medical Device Problem Code	Intermittent Shock/Stimulation (2287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref to natus complaint# (b)(4).Completed adverse event questionnaire was received from the customer.According to the questionnaire responses, the patient reported she felt a shock from the electrodes.The electrodes were changed out but still the patient complained of shocking coming from the frontal/channels.No medical attention was needed.There are no capa's related to this issue.This complaint does not identify a deficiency in the product design and therefore a capa is not required.Per (b)(4) xltek eeg psg ras, hazard id - 3.1, severity 11 - critical, risk is considered moderate.A risk review is not required as this complaint does not describe a new failure mode or new harm and the existing hazard severity and/or probability of occurrence has not changed per (b)(4), complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.Install date: 006562o3529 - july 21, 2020.Affected breakout box was returned.Awaiting investigation results.
Event or Problem Description
Emu40ex breakout box-refurb - the customer reports that when connected to a patient with electrodes, some shocks are being sent to the patient via fp1 and fp2.They used the same headbox on a different patient and the shocking still happened.No medical attention was needed.
Additional Manufacturer Narrative
Follow up ref to natus complaint# (b)(4).28-sep-2022: investigation results were received.Engineering evaluated the unit.Engineering observed no other damage on the device.Some electrode connectors, including fp1, fp2, ref and gnd had a faint black residue ring, which was easily wiped away with 70% isopropyl alcohol wipe.Therefore leading to the conclusion that this residue was dirt and grime, rather than corrosion damage from static shock/discharge.Engineering ran a 24 hour long study on neuroworks with the device and no voltage spikes or other concerning events were observed.The device was able to measure the input signals as expected.Leading to the conclusion that the device is functional as expected.The conclusion is that any shock event occurred as an unrelated external event from other equipment, or the environment in which the device was used in.Faillure confirmed: no.Investigation result code: neuro sbu|no issues noted.Closure rationale: complaint could not be verified, monitor for future occurrence.
Event or Problem Description
Emu40ex breakout box-refurb - the customer reports that when connected to a patient with electrodes, some shocks are being sent to the patient via fp1 and fp2.They used the same headbox on a different patient and the shocking still happened.No medical attention was needed.

• Brand Name: EMU40EX BREAKOUT BOX-REFURB
• Common Device Name: EMU40EX BREAKOUT BOX-REFURB
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; dba excel-tech ltd. (xltek); 2568 bristol circle; oakville, ontario l6h 5s1, ; CA
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway h91pd92, ; EI
• Manufacturer Contact: walsh ; dba excel-tech ltd. (xltek); 2568 bristol circle; oakville, ontario l6h 5s1, ; CA
• MDR Report Key: 14402884
• Report Number: 9612330-2022-00026
• Device Sequence Number: 5451435
• Product Code: GWQ
• UDI-Device Identifier: 00382830011297
• UDI-Public: 00382830011297
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2022

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
• Date Returned to Manufacturer: 04/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 05/14/2022
• Supplement Report FDA Received Date: 10/23/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown