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

Model Number	500010-001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	12/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging an incourage device caused a stroke in the patient's eye during therapy.There was no allegation of a device malfunction.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.

• Brand Name: INCOURAGE DEVICE
• Common Device Name: PERCUSSOR, POWERED-ELECTRIC
• 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: 13289386
• Report Number: 3004961434-2022-00001
• Device Sequence Number: 17325452
• Product Code: BYI
• UDI-Device Identifier: 00841561102778
• UDI-Public: 00841561102778
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/19/2022

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: 500010-001
• Device Catalogue Number: 500010-001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2020
• 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