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

Model Number	R500055-000
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging an incourage vest therapy device caused a broken rib.The patient discontinued vest therapy.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 encourage vest therapy device caused a broken rib.The patient discontinued vest therapy.The device was returned to the manufacturer for evaluation and the customer's complaint was not confirmed.The device passed all testing and operated as designed.

• Brand Name: INCOURAGE DEVICE
• Common Device Name: PERCUSSOR, POWERED-ELECTRIC
• Manufacturer (Section D): RESPIRATORY TECHNOLOGIES INC.; 5905 nathan lane north; plymouth MN 55442
• MDR Report Key: 11598892
• Report Number: 3004961434-2021-00003
• Device Sequence Number: 17018698
• Product Code: BYI
• UDI-Device Identifier: 00841561102785
• UDI-Public: 00841561102785
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/14/2021

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: 05/06/2021
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 03/31/2021
• Supplement Report FDA Received Date: 05/14/2021
• 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