MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION THE VEST SYSTEM; PERCUSSOR, POWERED-ELECTRIC

Model Number	P105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: a device history review revealed no issues that could have caused or contributed to the reported issue.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a patient sustained a compression fracture during use of a volara vest.Approximately one and a half years ago, the patient was ¿putting a dish in the dishwasher, heard a crack and experienced back pain.¿ they initially consulted their healthcare provider, and a cortisone injection was provided; along with an x-ray.The x-ray results showed no injuries.The patient continued to have pain and returned to their doctor three days later.The doctor ordered an magnetic resonance imaging (mri), and a compression fracture was identified.The patient was advised to take pain relief medication (not further specified) and wear a brace.Around that same time, the patient was hospitalized for an unrelated issue.During hospitalization, the patient required a computed tomography scan (ct) and the results identified three compression fractures.The patient¿s physician stated the patient¿s four years of prednisone use and the volara therapy contributed to the compression fractures.The patient has not used the volara vest since (for a year and a half).Patient states they still have pain; however, they no longer require medical attention.There was no report of device malfunction.No further information was available at the time of this report.

• Brand Name: THE VEST SYSTEM
• Common Device Name: PERCUSSOR, POWERED-ELECTRIC
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): HILL-ROM SINGAPORE; 1 yishun avenue 7; singapore, north east 76892 3; SN 768923
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22798596
• Report Number: 3008145987-2025-00005
• Device Sequence Number: 8286773
• Product Code: BYI
• UDI-Device Identifier: 00887761997776
• UDI-Public: (01)00887761997776
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2025

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: P105
• Device Catalogue Number: P105A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown