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

Model Number	AW-S030
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, while in use on a patient, the clinician had an issue with passing a 8french catheter through this 3.0 sonarmed sensor.The catheter fit but was so tight and took so long to advance it occluded the endotracheal tube (ett) that the baby started to ¿brady¿.Although requested, information pertaining to patient intervention and outcome has not been provided.
Additional Manufacturer Narrative
H3: the device was not returned for evaluation.The investigation is currently in progress.There is an existing previous internal investigation regarding the reported issue.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Section h9: 806 number 3009023584-03-08-2024-01-r section h6 evaluation codes updated due to completion of investigation result - add additional code conclusion - remove d15 and add d03 component - remove g07003 and add g03012 it was reported that, while in use on a patient, the clinician had an issue with passing a 8french catheter through this 3.0 sonarmed sensor.Although requested, information pertaining to patient intervention and outcome has not been provided.No physical product or photos were returned for analysis.Although no product was returned, the likely cause of the issue was isolated to an obstruction in the sensor.An existing corrective action addresses the issue.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.

• Brand Name: SONARMED
• Common Device Name: AIRWAY MONITORING SYSTEM
• Manufacturer (Section D): SONARMED, INC.; 12220 n. meridian street; suite 150; carmel,in 46032 ; IN 46032
• Manufacturer (Section G): SONARMED, INC.; 12220 n. meridian street; suite 150; carmel,in 46032 ; IN 46032
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18883100
• Report Number: 1282497-2024-00029
• Device Sequence Number: 14202583
• Product Code: OQU
• UDI-Device Identifier: 00851334007193
• UDI-Public: 00851334007193
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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-S030
• Device Catalogue Number: AW-S030
• 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: 03/08/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1520-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown