MAUDE Adverse Event Report: RESPIRATORY TECHNOLOGIES, INC. THE INCOURAGE SYSTEM; AIRWAY CLEARANCE VEST THERAPY

Model Number	ICS-1M-US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, the device has not been returned for analysis.Without the return of the product, no conclusions can be made regarding the event.If additional information is received, a supplemental report will be submitted.Multiple attempts have been made to obtain additional information regarding patient information, patient outcome, and whether patient received additional intervention.At this time no further information has been made available to respiratory technologies.If additional information is received a supplemental report will be submitted.
Event or Problem Description
Respiratory technologies received information during routine follow-up that a patient experienced a rupture of one of the patient's saline breast implants following the use of the incourage airway clearance therapy system.There have been no adverse events reported by the patient in the months since the event occurred.The patient had consulted with her physician and the physician stated there are no risks due to the rupture.The incourage device has not yet been returned for analysis, but product return is expected.

• Brand Name: THE INCOURAGE SYSTEM
• Common Device Name: AIRWAY CLEARANCE VEST THERAPY
• Manufacturer (Section D): RESPIRATORY TECHNOLOGIES, INC.; 2896 centre pointe driver; saint paul MN 55113
• MDR Report Key: 7057949
• Report Number: 3004961434-2017-00001
• Device Sequence Number: 977588
• Product Code: BYI
• UDI-Device Identifier: 00841561102778
• UDI-Public: 00841561102778
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2017

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
• Device Catalogue Number: ICS-1M-US
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 11/24/2017
• 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 Age: 57 YR