MAUDE Adverse Event Report: RESPIRATORY TECHNOLOGIES INCOURAGE DEVICE; PERCUSSOR, POWERED-ELECTRIC

Model Number	R500055-000
Medical Device Problem Codes	Contamination (1120); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cough (4457)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging an incourage device caused a patient to cough up blood during therapy.There was no allegation of a device malfunction.The patient discontinued use of the device.The device has yet to be returned to the manufacturer for evaluation.A follow up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported an incourage device allegedly caused a patient to cough up blood during therapy.There was no allegation of a device malfunction.The patient discontinued use of the device.The device was returned to a third party service center for evaluation.During the evaluation of the device contamination was observed and the device was scrapped.

• Brand Name: INCOURAGE DEVICE
• Common Device Name: PERCUSSOR, POWERED-ELECTRIC
• Manufacturer (Section D): RESPIRATORY TECHNOLOGIES; 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: 14103307
• Report Number: 3004961434-2022-00003
• Device Sequence Number: 6428474
• 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
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2023

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 Model Number: R500055-000
• Device Catalogue Number: R500055-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2022
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2021
• 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