MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED NATUS BASE UNIT

Model Number	016862
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref to natus complaint# (b)(4).(b)(6) 2022: district sales manager reports unit defective, there are sparks when plugging a breakout box into it.Customer provided video.(b)(6) 2022: follow up email sent to tech support for 2nd request for ae questionnaire and 2nd request for better video showing spark.Tech support responded they sent questionnaire to customer, no response yet and they do not have a better video.(b)(6) 2022: follow up email sent to tech support for 3rd request for ae questionnaire and 2nd request for alleged defective item be returned.Tech support responded they sent request again.(b)(6) 2022: per information received from risk manager, not a risk hazard.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), complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.Dhr reviewed, and no related faults/issue found.Install date: (b)(6) 2022.Further investigation to be carried out.The affected product to be evaluated.
Event or Problem Description
Part 016862 natus base unit - district sales manager reports unit defective, there are sparks when plugging a breakout box into it.Customer provided video.Follow up emails sent to technical support for 3rd request for adverse event questionnaire and 2nd request for alleged defective item be returned for evaluation.
Additional Manufacturer Narrative
Follow up report 001.Ref to natus complaint#(b)(4).Acceptable risk associated with the complaint as per hazard id line 5.101 in doc-(b)(4) xltek eeg psg ras risk analysis spreadsheet.Severity-3.No death or serious injury, considered a customer inconvenience, low risk to user.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.(b)(4) has been opened for investigation.On 13-dec-2022: the affected unit in question was shipped to engineering for investigation.The affected product to be evaluated, awaiting investigation results.
Event or Problem Description
Part 016862 natus base unit - district sales manager reports unit defective, there are sparks when plugging a breakout box into it.Customer provided video.Follow up emails sent to technical support for 3rd request for adverse event questionnaire and 2nd request for alleged defective item be returned for evaluation.
Additional Manufacturer Narrative
Follow up report 002.Ref to natus complaint#(b)(4).February 14, 2023 engineering provided investigation results: there were no indications inside the customer base unit that the reported sparking event was caused by an internal hardware malfunction.The reported issue could not be reproduced, however, the base unit did exhibit failure on the usb communication lines, possibly as a result from the sparking event described by the customer.It may be possible, if an electrical discharge were to occur near the aluminum plate on the back of the base, that it could couple to the usb communication pins, causing damage down the line on the qseven module, but this is extremely unlikely and has not been successfully reproduced.It is unlikely that the failure happened internally, as only 1 communication line is unstable, all power lines work as intended, and no other damage can be seen on or in the device.The root cause of the sparking event could not be determined nor observed nor did the provided video match the description of the failure.The sparking may be related to the customer site or setup, further investigation may be needed.We did not receive a response from request of information from customer.Failure confirmed: no.Investigation result code: neuro sbu|no issues noted.Closure rationale: complaint could not be verified, monitor for future occurrence.Low safety risk of harm, individual complaint related to issue stated.Complaint will be included in trending data for further review and investigation if needed.
Event or Problem Description
Part 016862 natus base unit : district sales manager reports unit defective, there are sparks when plugging a breakout box into it.Customer provided video.Follow up emails sent to technical support for 3rd request for adverse event questionnaire and 2nd request for alleged defective item be returned for evaluation.

• Brand Name: NATUS BASE UNIT
• Common Device Name: NATUS BASE UNIT
• 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: 15874745
• Report Number: 9612330-2022-00051
• Device Sequence Number: 16761295
• Product Code: GWQ
• UDI-Device Identifier: 00382830047265
• UDI-Public: 00382830047265
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 02/17/2023

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: 016862
• Device Catalogue Number: 016862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: 11/02/2022; 11/02/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 12/20/2022; 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2022
• 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