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

Model Number	500055-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging an incourage device caused the patient's defibrillator to discharge while using the device.There was no report of medical intervention being required.The device was returned to the manufacturer for evaluation.The manufacturer found no issues with the device.The manufacturer found the device to be contaminated with a liquid.The device was scrapped by the manufacturer.

• 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: 12908403
• Report Number: 3004961434-2021-00008
• Device Sequence Number: 19834738
• Product Code: BYI
• UDI-Device Identifier: 00841561102785
• UDI-Public: 00841561102785
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2021

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: 500055-000
• Device Catalogue Number: 500055-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2020
• Initial Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown