MAUDE Adverse Event Report: RESPIRATORY TECHNOLOGIES, INC INCOURAGE DEVICE; PERCUSSOR

Model Number	ICS-1M-US
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation report will be provided in the follow-up report.
Event or Problem Description
Respirtech received a report from the patient's mother stating that the device "burst" and that a fire occurred at the residence.An investigation was conducted by the local fire department.According to the official fire investigation report, the fire originated on or near the bed on the east wall of the trailer.The investigator was unable to rule out either the electrical cord to the device to the incourage device or a candle located on the desk as potential sources.Based on the evidence and scene conditions, the fire was classified as accidental.At this time, there is no conclusive evidence identifying the device as the definitive cause of the fire.Respirtech will continue to monitor for any additional information that may become available.
Event or Problem Description
Respirtech received a report from the patient's mother stating that the device "burst" and that a fire occurred at the residence.An investigation was conducted by the local fire department.According to the official fire investigation report, the fire originated on or near the bed on the east wall of the trailer.The investigator was unable to rule out either the electrical cord to the device to the incourage device or a candle located on the desk as potential sources.Based on the evidence and scene conditions, the fire was classified as accidental.At this time, there is no conclusive evidence identifying the device as the definitive cause of the fire.Respirtech will continue to monitor for any additional information that may become available.
Additional Manufacturer Narrative
Follow-up reports are on file.

• Brand Name: INCOURAGE DEVICE
• Common Device Name: PERCUSSOR
• Manufacturer (Section D): RESPIRATORY TECHNOLOGIES, INC; 5905 nathan lane north; suite 200; plymouth MN 55442
• Manufacturer (Section G): RESPIRATORY TECHNOLOGIES, INC; 5905 nathan lane north; plymouth MN 55442
• Manufacturer Contact: daniel wilkinson ; 5905 nathan lane north; plymouth, MN 55442
• MDR Report Key: 23404915
• Report Number: 3004961434-2025-00001
• Device Sequence Number: 14681609
• Product Code: BYI
• UDI-Device Identifier: 00841561102785
• UDI-Public: 00841561102785
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K051383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: ICS-1M-US
• Device Catalogue Number: R500055-011
• Device Lot Number: 16011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2025
• 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: Life Threatening
• Patient Sex: Unknown