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	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient's daughter said the patient has been in the hospital with pneumonia and a broken rib.Suspects that it is from the device.

• 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: 25665421
• Report Number: 3004961434-2026-00006
• Device Sequence Number: 10452580
• 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): 09/29/2026

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: R500055-000
• Device Lot Number: 17021
• 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: 06/30/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown