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

Model Number	R500055-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging an incourage vest therapy interfered with a patient's pacemaker.The issue was noted by the patient's cardiologist.The device has yet to be returned to the manufacturer for evaluation.At this time, we are unable to confirm the alleged malfunction.A follow-up report will be submitted when the manufacturer's investigation is complete.
Additional Manufacturer Narrative
The manufacturer previously reported an incourage vest therapy interfered with a patients pacemaker.The issue was noted by the patient's cardiologist.There was no information received to indicate serious or permanent patient harm or injury.The device was returned to the manufacturer for evaluation and the customer's complaint could not be confirmed.The device was found to operate as designed and passed all testing.

• Brand Name: INCOURAGE SYSTEM
• Common Device Name: PERCUSSOR, POWERED-ELECTRIC
• Manufacturer (Section D): RESPIRATORY TECHNOLOGIES INC.; 5905 nathan lane north; plymouth, mn
• MDR Report Key: 10460886
• Report Number: 3004961434-2020-00001
• Device Sequence Number: 19651802
• Product Code: BYI
• UDI-Device Identifier: 00841561102785
• UDI-Public: 00841561102785
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 01/15/2021

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: R500055-000
• Device Catalogue Number: R500055-000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 01/19/2021
• 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