MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED NATUS BRAIN MONITOR BREAKOUT

Model Number	021911
Medical Device Problem Code	Electrostatic Discharge (2149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref natus complaint# (b)(4).The defective device was requested to be returned to natus for evaluation.Information was also requested on what electrodes were used.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 qms-004442, complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.A dhr review is not applicable because, prior to the reported issue the device was in service for 2 or more years and a manufacturing defect is very unlikely.Install date: (b)(6) 2019.Further investigation to be carried out.
Event or Problem Description
Part 021911 natus brain monitor breakout.2 patients said they could feel something when the electrodes were applied and the study was running.The first patient described the feeling as being cold, the second patient described it as static feeling she could feel all over her body.No patient injury.
Event or Problem Description
Part 021911 natus brain monitor breakout - 2 patients said they could feel something when the electrodes were applied and the study was running.The first patient described the feeling as being cold, the second patient described it as static feeling she could feel all over her body.No patient injury.
Additional Manufacturer Narrative
Follow up report 001 ref natus complaint# (b)(4).Natus received the suspect device back.The repair technician performed the evaluation and confirmed the device passed all the tests.The following was noted: ran the safety test per procedure qms-006941 and it passed all tests.Ran the functional test per procedure qms-003367 and it passed all tests.The product was then forwarded to natus engineering for further evaluation.Currently waiting for feedback.Confirmation was received on type of electrodes used by customer - rochester disposable gold electrodes.
Event or Problem Description
Part 021911 natus brain monitor breakout - 2 patients said they could feel something when the electrodes were applied and the study was running.The first patient described the feeling as being cold, the second patient described it as static feeling she could feel all over her body.No patient injury.
Additional Manufacturer Narrative
Follow up report 002 ref natus complaint# (b)(4).Brain monitor unit was product tested for functionality and safety with unit found operational with no defect.Units are being retained in engineering in the event a trend is found allowing this unit to be further inspected.Per (b)(4) xltek eeg psg risk analysis, hazard id 11.1, severity 11-critical, risk level-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.Failure confirmed: no.Investigation result code: neuro sbu|no issues noted.

• Brand Name: NATUS BRAIN MONITOR BREAKOUT
• Common Device Name: NATUS BRAIN MONITOR BREAKOUT
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; dba excel-tech ltd.; 2568 bristol circle; oakville, ontarios, l6h 5s1, ; CA
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway, H91PD 92; EI H91PD92
• Manufacturer Contact: gráinne walsh ; dba excel-tech ltd.; 2568 bristol circle; oakville, ontarios,, L6H 5-S1 ; CA L6H 5S1
• MDR Report Key: 17314509
• Report Number: 9612330-2023-00018
• Device Sequence Number: 3957405
• Product Code: OLV
• UDI-Device Identifier: 00382830047258
• UDI-Public: 00382830047258
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K042223
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2023

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: 021911
• Device Catalogue Number: 021911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 06/15/2023; 06/15/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 09/08/2023; 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown