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

Model Number	M08368
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Respiratory Tract Infection (2420)
Date of Event	12/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a customer developed an infection while using a the vest apx.The customer contacted baxter to report they became ¿very sick¿ and wasn¿t sure ¿if the vest caused it or not.¿ the customer made an appointment with their health care provider; however, the customer could not get there in time.Therefore, the customer visited the urgent care instead.At the urgent care the customer was given prednisone, ¿an antibiotic to break up the congestion¿ and promethazine.Additionally, there was no report of device malfunction.No further information was available at the time of this report.

• Brand Name: THE VEST APX 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: 24201499
• Report Number: 3008145987-2026-00009
• Device Sequence Number: 9635457
• Product Code: BYI
• UDI-Device Identifier: 00887761967366
• UDI-Public: (01)00887761967366(11)990312
• 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): 01/28/2026

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: Lay User/Patient
• Device Model Number: M08368
• Device Catalogue Number: PVAPX1HC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/1999
• 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: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female