MAUDE Adverse Event Report: Respiratory Technologies, Inc InCourage device; Percussor

Model Number	ICS-1M-US
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Outcomes representative spoke with the patient for 12-month outcomes who said he returned the therapy to the va last october as it broke vertebra in his back.The patient did not know the name of the medical doctor who treated him, and said he has recovered and is doing okay.

• 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: 25537183
• Report Number: 3004961434-2026-00005
• Device Sequence Number: 15888883
• Product Code: BYI
• UDI-Device Identifier: 00841561102785
• UDI-Public: 00841561102785
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051383
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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
• Device Model Number: ICS-1M-US
• Device Catalogue Number: 500055-200
• Device Lot Number: M1079022022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/17/2026
• Supplement Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (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