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

Model Number	ICS-1M-US
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Grounding Malfunction (1271)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The patient states device has burned terminals where cord plugs in the back.

• Brand Name: INCOURAGE DEVICE
• Common Device Name: PERCUSSOR
• Manufacturer (Section D): RESPIRATORY TECHNOLOGIES, INC; 5905 nathan lane north; 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: 24637711
• Report Number: 3004961434-2026-00001
• Device Sequence Number: 9842799
• Product Code: BYI
• UDI-Device Identifier: 00841561102785
• UDI-Public: 00841561102785
• Combination Product (Y/N): N
• PMA/510(K) Number: K051383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/28/2022
• Device Model Number: ICS-1M-US
• Device Catalogue Number: R500055-011
• Device Lot Number: M1019122022
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown