MAUDE Adverse Event Report: RESPIRATORY TECHNOLOGIES, INC INCOURAGE DEVICE; 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	08/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, pt reported she was having discomfort in back while doing therapy.On 08/23 pt reported she has compression fractures in back clinical resource specialist reviewed the patient's medical records, the patient has a history of compression fractures.The patient is returning the device, she cannot tolerate therapy.
Event or Problem Description
On (b)(6) 2024 the patient reported she was having discomfort in her back while doing therapy.On (b)(6) 2024 the patient reported she had compression fractures in her back.Clinical resource specialist reviewed the patient's medical records, the patient has a history of compression fractures.The patient is returning the device, she cannot tolerate 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: david douglas ; 5905 nathan lane north; plymouth, MN 55442
• MDR Report Key: 20100496
• Report Number: 3004961434-2024-00003
• Device Sequence Number: 7664447
• 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): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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: 06/14/2023
• Device Model Number: ICS-1M-US-A
• Device Lot Number: 16616
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2023
• 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: Female