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	03/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient left a voicemail, reports in fall/autumn (2025) as she was increasing pressure she had rib pain and backed off the pressure.States she broke her ribs but was not aware at the time.Says does not have osteoporosis but her body reacts like she does.Ct scan on (b)(6) 2026 shows multiple rib fractures on right side, knows she didn't fall.Only time she had pain was when she was increasing pressure on vest.Wants us to call back if we need to or put that information in her file.
Event or Problem Description
The patient left a voicemail, reports in (b)(6) (2025) as she was increasing pressure she had rib pain and backed off the pressure.States she broke her ribs but was not aware at the time.Says does not have osteoporosis but her body reacts like she does.Ct scan (b)(6) 2026 shows multiple rib fractures on right side, knows she didn't fall.Only time she had pain was when she was increasing pressure on vest.Wants us to call back if we need to or put that information in her file.
Additional Manufacturer Narrative
The patient wants to keep the device and continue therapy.

• 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: 24700456
• Report Number: 3004961434-2026-00002
• Device Sequence Number: 13273424
• Product Code: BYI
• UDI-Device Identifier: 00606959420571
• UDI-Public: 00606959420571
• 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): 05/11/2026

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: 06/29/2023
• Device Model Number: ICS-1M-US
• Device Catalogue Number: R500055-011
• Device Lot Number: 16613
• 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): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 05/11/2026
• 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