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

Model Number	P205CM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Cardiac Arrest (1762); Vomiting (2144)
Date of Event	01/29/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The investigation is ongoing, however if any additional relevant information is identified following the completion of the investigation, the additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Event or Problem Description
Baxter received a report that a patient passed away while using a vest 205 therapy device.The patient was hospitalized at the time for suspected pneumonia or viral meningitis.This was the patient¿s first use of the device, and therapy was initiated by hospital staff who subsequently left the room.Within approximately two minutes, the patient reportedly began vomiting and aspirating fluid, followed by a decrease in heart rate.No hospital caregivers were present in the room at the time, and it is unknown whether any life sustaining measures were attempted.The patient subsequently expired that same day.The reported cause of death listed as viral meningitis.It was not reported if an autopsy was performed.Per the instructions for use state the device "we recommend your first use of this product be in a supervised setting such as a doctor¿s office or at home with a clinical trainer".There was no allegation of a device malfunction, and the healthcare facility has not identified the specific device involved.No further information was available at the time of this report.
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.

• 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 ; 2242705355
• MDR Report Key: 24749661
• Report Number: 3008145987-2026-00022
• Device Sequence Number: 12956797
• Product Code: BYI
• UDI-Device Identifier: 00887761997431
• UDI-Public: (01)00887761997431
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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: Other
• Device Model Number: P205CM
• Device Catalogue Number: P205CM
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 34 KG