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	Vertebral Fracture (4520)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The manufacturer received information alleging an incourage device caused a compressed spine fracture.The patient was initially hospitalized for three days and then transferred to rehabilitation.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 device allegedly caused a compressed spine fracture.The patient was initially hospitalized for three days and then transferred to rehabilitation.The device was returned to the manufacturer for evaluation and the customer's complaint was unable to be confirmed.The device was tested and found to operate to design specification.The manufacturer concludes no further action is needed at this time.

• 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: 11281109
• Report Number: 3004961434-2021-00001
• Device Sequence Number: 715332
• Product Code: BYI
• UDI-Device Identifier: 00841561102785
• UDI-Public: 00841561102785
• Combination Product (Y/N): N
• Initial Reporter State: WY
• 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: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2021

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: 02/25/2021
• Initial Date Received by Manufacturer: 01/12/2021
• Supplement Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 03/25/2021
• 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: Hospitalization