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

Model Number	021920
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Part 021920 natus brain monitor breakout - the doctor confirmed that the patient moved, pulled out the wires, and the breakout box fell on him.No injuries.
Additional Manufacturer Narrative
Initial report ref natus complaint# (b)(4).The customer returned a competed adverse event questionnaire.Per the customer, the patient rolled over in the middle of the night and pulled on the wires causing the breakout box to fall on his head.One side of the rubber loop at the top of the box came out so the box fell from its hook.The customer confirmed there was no death or serious injury and no medical intervention was needed.The customer states that the breakout box is not broken but can be returned if requested.Per doc-010378 xltek eeg psg risk analysis spreadsheet, hazard id - 6.12, severity 11 - critical, the risk is considered moderate.Install date: (b)(6) 2023.Further investigation to be carried out.
Additional Manufacturer Narrative
Follow up report 001 ref natus complaint#(b)(4).A natus specialist went onsite and checked each headbox and found that all removable handles are intact without rips or tears.Capa004628.Was previously opened to investigate loose handles.Serial number not provided.Per doc-010378 xltek eeg psg risk analysis spreadsheet, hazard id - 6.10, severity 11 - critical, the 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 qms-004442, complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.Faillure confirmed: no investigation result code: neuro sbu|no issues noted closure rationale: complaint will be included in trending data for further review.
Event or Problem Description
Part 021920 natus brain monitor breakout - the doctor confirmed that the patient moved, pulled out the wires, and the breakout box fell on him.No injuries.

• 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: 17422888
• Report Number: 9612330-2023-00020
• Device Sequence Number: 7572412
• Product Code: GWQ
• UDI-Device Identifier: 00382830047241
• UDI-Public: 00382830047241
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K180290
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023

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: 021920
• Device Catalogue Number: 021920
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/18/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 08/23/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: White