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	Skin Erosion (2075)
Date of Event	06/16/2025
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 patient sustained compression ulcers during use of a vest apx system.The patient reportedly incurred compression ulcers in their stomach and they became infected.The patient was seen by their healthcare provider (hcp) and was prescribed unspecified antibiotics.The hcp advised the patient to hold off on use of the device; however, the patient has chosen to discontinue the vest.Additionally, there was no report of a device malfunction.No further information was available at the time of this report.
Additional Manufacturer Narrative
Additional information: d9, h3, h6 and h11.H11: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The vest underwent functional testing and performed according to product specifications.The reported condition was not verified.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.A device history review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.

• 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 ; 2242702068
• MDR Report Key: 22806672
• Report Number: 3008145987-2025-00006
• Device Sequence Number: 15403297
• Product Code: BYI
• UDI-Device Identifier: 00887761967366
• UDI-Public: (01)00887761967366(17)990428
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/1999
• 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 Age: 74 YR
• Patient Sex: Female