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	05/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient's daughter says that the patient is unable to tolerate the vest anymore.The patient doesn't like the vest and hasn't used it for several months.The doctor told them they can return the device.The patient is very tiny, and they found she has three cracks in her spine, unsure of how it happened.The patient was offered a comfort wrap, but the patient's daughter said she wouldn't use it.
Event or Problem Description
The patient's daughter says that the patient is unable to tolerate the vest anymore.The patient doesn't like the vest and hasn't used it for several months.The doctor told them they can return the device.The patient is very tiny, and they found she has three cracks in her spine, unsure of how it happened.The patient was offered a comfort wrap, but the patient's daughter said she wouldn't use it.
Additional Manufacturer Narrative
The device operated as expected; however, it was damaged and scrapped.

• 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: 25412491
• Report Number: 3004961434-2026-00004
• Device Sequence Number: 12194309
• Product Code: BYI
• UDI-Device Identifier: 00606959420540
• UDI-Public: 00606959420540
• Combination Product (Y/N): N
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Model Number: ICS-1M-US
• Device Catalogue Number: R500055-000
• Device Lot Number: 17011
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2026
• Supplement Report FDA Received Date: 09/11/2026
• 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
• Patient Sex: Unknown