MAUDE Adverse Event Report: RESPIRATORY TECHNOLOGIES INC. INCOURAGE SYSTEM; PULSATING VEST THERAPY

Model Number	ICS-1M-US-A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	09/24/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient had been using vest therapy successfully for 6 months, then was hospitalized for an unrelated condition.After being discharged, patient resumed vest therapy and after three sessions, patient developed shortness of breath.Patient was taken to the er and found to have a pneumothorax on the left and was admitted.Spouse states that hospital physicians do not know cause of pneumothorax.Followed up with patient's pulmonologist who said that at this time they feel the pneumothorax is unrelated to vest use, however they cannot make an absolute determination.Results of manufacturer testing of returned device: the device was found to be operating normally within defined specifications.

• Brand Name: INCOURAGE SYSTEM
• Common Device Name: PULSATING VEST THERAPY
• Manufacturer (Section D): RESPIRATORY TECHNOLOGIES INC.; 2896 centre pointe drive; st paul MN 55113
• MDR Report Key: 8019124
• Report Number: 3004961434-2018-00002
• Device Sequence Number: 13863154
• Product Code: BYI
• UDI-Device Identifier: 00841561102785
• UDI-Public: 00841561102785
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/02/2018

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: ICS-1M-US-A
• Device Catalogue Number: 500055-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/30/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 79 YR