MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION THE VESTSYSTEM; 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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned and the serial number is unknown; 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 fraction while using a vest in the hospital.The patient was admitted to the hospital for pneumonia and bronchiectasis post bronchoscopy procedure.While hospitalized the patient was being treated with the hospital¿s disposable vest.On an unknown date the patient complained of ¿severe back pain¿ and underwent a computed tomography scan (ct).The ct showed a compression fracture of the t6 vertebra.The patient reported that the healthcare provider (hcp) could not tell for certain if the use of the device caused the injury but based on the location, the hcp suspected that it could have contributed.Per the patient, the hcp also noted that their coughing and steroid use could also have contributed to the injury.It was noted that the patient had to wear a back brace to restrict their movement until the fracture eventually healed without further medical intervention.Additionally, there was no report of device malfunction.The exact cause is unknown at this time, but likely multifactorial due to the patient¿s medical history of osteoporosis and coughing and steroid usage which may have been contributing factors.No further information was available at the time of this report.

• Brand Name: THE VESTSYSTEM
• Common Device Name: PERCUSSOR, POWERED-ELECTRIC
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): HILL-ROM ST. PAUL; 1020 west county road f; st. paul MN 55126
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22078783
• Report Number: 2183816-2025-00028
• Device Sequence Number: 21008353
• Product Code: BYI
• UDI-Device Identifier: 00887761997776
• UDI-Public: (01)00887761997776
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/23/2025

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: P105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 05/23/2025
• 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
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 52 KG