MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED TREX HD HEADBOX

Model Number	008043
Medical Device Problem Code	Electromagnetic Interference (1194)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref natus complaint (b)(4).(b)(6) 2023: natus received notification of the complaint from the fda via medwatch report.(uf/importer report# (b)(4) ).(b)(6) 2023: a adverse event questionnaire was sent to the customer.The customer was also asked if they still had the device that was used during the procedure.A related case (b)(4) was opened against this product in (b)(6) 2020 for the same account with repairs done in (b)(6) 2020.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 device history record 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) 2020.Further investigation to be carried out.
Event or Problem Description
Patient felt the a-eeg equipment may have been frequently but not constantly interfering with his pm-defibrillator device.
Event or Problem Description
Patient felt the a-eeg equipment may have been frequently but not constantly interfering with his pm-defibrillator device.
Additional Manufacturer Narrative
Follow up report 001 ref natus complaint# (b)(4).Related to fda medwatch report - uf/importer report# (b)(4).Per doc-010378 hazard id 5.1, severity 3-negligible risk level low.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.It was also noted, that there is a statement in 019694 trex hd instructions for use (ifu) "the trex hd monitoring uses radiofrequency (rf) energy only for its internal function.Therefore, its rf emissions are very low and are not likely to cause any interference in nearby electronic equipment." four attempts were made to have the product returned.26 june 2023: it has been at least 45 days since the customer was informed that the return of the part is necessary for investigation.The part has not been received back.Faillure confirmed: no.Investigation result code: neuro sbu|product not returned.Closure rationale: complaint could not be verified, materials not returned for analysis.Complaint will be included in trending data for further review.

• Brand Name: TREX HD HEADBOX
• Common Device Name: TREX HD HEADBOX
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; dba excel-tech ltd.; 2568 bristol circle; oakville, ontario, L6H 5 S1; CA L6H 5S1
• 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, ontario, L6H 5-S1 ; CA L6H 5S1
• MDR Report Key: 16874683
• Report Number: 9612330-2023-00005
• Device Sequence Number: 14910487
• Product Code: GWQ
• UDI-Device Identifier: 00382830015639
• UDI-Public: 00382830015639
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K162595
• 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): 06/30/2023

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: 008043
• Device Catalogue Number: 008043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 55 YR
• Patient Sex: Male