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

Model Number	ICS-1M-US-A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient stated: i use nebulizer at the same time as the vest.I cannot tell which one helps me more.I have not used the vest for about a week due to rib separation.I should start back in 2 weeks.I was using 1x per day for 30 minutes at 55% pressure.Outcomes spoke with the patient's daughter who advised that the patient will not use therapy as he said it is not benefiting him and feels it caused his rib pain.Os advised about reducing time and pressure, but she said the patient was firm in the decision to return and that his hct said he could discontinue therapy.The device will be returned.

• Brand Name: INCOURAGE
• 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: david douglas ; 5905 nathan lane north; plymouth, MN 55442
• MDR Report Key: 20272855
• Report Number: 3004961434-2024-00004
• Device Sequence Number: 14320219
• Product Code: BYI
• UDI-Device Identifier: 00841561102785
• UDI-Public: 00841561102785
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2024

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 Expiration Date: 10/04/2021
• Device Model Number: ICS-1M-US-A
• Device Lot Number: 15708
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown