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 embla sdx breakout - the doctor reported that the headbox fell on a patient's head because the rubber handle came off.
Additional Manufacturer Narrative
Initial report ref natus complaint# (b)(4).The patient was sleeping when the sdx box suddenly fell and hit the patient on the head.No injuries.Serial number of affected device not confirmed.Further investigation to be carried out.
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
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.Section d4 - serial number not provided.Per (b)(4).Xltek eeg psg risk analysis spreadsheet, hazard id - 6.13, severity 11 - critical, the risk is considered moderate.Per (b)(6).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.

• 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: 17430785
• Report Number: 9612330-2023-00022
• Device Sequence Number: 12560309
• 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: 07/28/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• 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 Sex: Unknown
• Patient Race: White