MAUDE Adverse Event Report: SONARMED, INC. SONARMED; AIRWAY MONITORING SYSTEM

Model Number	AW-M0001
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section h9: 806 number 3009923584-12212021-01-r this report is being submitted as part of remediation activities associated with capa#643143, which is addressing mdr reporting guidance from fdas 1995 preamble, which ensures complaints related to corrections and recalls which were previously reported to fda under 21 cfr 806 are not reported as mdrs; this is not a new malfunction/event.H3 device evaluation summary: reportability reassessed based on the 806 report submitted to the fda.Medtronic conducted an investigation based upon all information received.It was reported that this sonarmed device had muffled speaker.The product sample or additional supporting materials from the account was not available for analysis.Based on the evidence available there was not enough information to make any determination.Without the sample a detailed investigation could not be performed, and definitive cause could not be identified.Based on the information provided in the event and/or other source, the suspected or most likely cause of the event could not be determined.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Further action was not required because the event is in scope for fca z-0514-2022.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that this sonarmed device had muffled speaker.The device was not in use on a patient at the time of the reported event.

• Brand Name: SONARMED
• Common Device Name: AIRWAY MONITORING SYSTEM
• Manufacturer (Section D): SONARMED, INC.; 12220 n. meridian street; suite 150; carmel IN 46032
• Manufacturer (Section G): SONARMED, INC.; 12220 n. meridian street; suite 150; carmel IN 46032
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20238637
• Report Number: 1282497-2024-00393
• Device Sequence Number: 8912574
• Product Code: OQU
• UDI-Device Identifier: 00851334007001
• UDI-Public: 00851334007001
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K193058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/17/2024

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: AW-M0001
• Device Catalogue Number: AW-M0001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 09/17/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0514-2022
• Patient Sequence Number: 1
• Patient Sex: Unknown