MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED TREX HD HEADBOX-REFURB

Model Number	008043R
Medical Device Problem Code	Loss of Data (2903)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref natus complaint#( b)(4).Reached out to the customer for further details.
Event or Problem Description
Natus received a user incident report concerning our product - trex hd headbox - report of "multiple instances of recording data lost during the device use.No injuries reported.
Event or Problem Description
Natus received a user incident report concerning our product - trex hd headbox - report of "multiple instances of recording data lost during the device use.No injuries reported.
Additional Manufacturer Narrative
Follow up report 001 ref natus complaint# (b)(4).Install date of device: aug-05-2021.Risk review: per (b)(4), rev 70 xltek eeg/psg risk analysis spreadsheet, hazard id 5.95, cause - invalid calculation, incorrectly scored events, or missed events by the signal detectors / analyzers in neuroworks /sleepworks.Effects (harm) -clinically insignificant -- no diagnosis or treatment made from analyzer results.The hazard identified has rba rating of negligible and is deemed broadly acceptable.These risks have been reviewed to determine if any further control measures may be implemented so as to further reduce the risk as far as possible.Risk outweighed by benefit of use of device.No related capa's.No further follow up action has been recorded or cross referenced for this complaint for at least 45 days.The service technician made multiple attempts to retrieve the adverse event questionnaire but received no response from the customer after several attempts.No unit has been returned and the customer has not called back for additional troubleshooting or to confirm this issue is ongoing.Review of customer's account found no additional related calls.Failure confirmed: no.Investigation result code: neuro sbu|product not returned.

• Brand Name: TREX HD HEADBOX-REFURB
• Common Device Name: TREX HD HEADBOX-REFURB
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; dba excel-tech ltd.; 2568 bristol circle; oakville, ontarios, L6H 5 S1; CA L6H 5S1
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway h91pd92, ; EI
• Manufacturer Contact: gráinne walsh ; dba excel-tech ltd.; 2568 bristol circle; oakville, ontarios, L6H 5-S1 ; CA L6H 5S1
• MDR Report Key: 18960142
• Report Number: 9612330-2024-00021
• Device Sequence Number: 20604271
• Product Code: GWQ
• UDI-Device Identifier: 00382830015639
• UDI-Public: 00382830015639
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2024

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: 008043R
• Device Catalogue Number: 008043R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 06/17/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown