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	Visual Disturbances (2140)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced ¿sudden vision distortion¿ while using a vest apx system.The patient relayed that when they use the vest, ¿the device shakes so much it shakes their eyes¿.The patient also described the distortion as having an ¿indentation on the left side¿ when looking at something round, and when looking at the newspaper it ¿seems to have holes in it.¿ the patient also reported the distortion had not resolved.The patient notified their ¿retina specialist¿ and was advised they ¿thin retinas." the specialist advised the patient to discontinue use of the vest device.The patient also notified their pulmonologist, who advised the patient to continue use, but lower device settings.There was no report of a device malfunction.The patient has chosen to discontinue use of the device, and the device will be returned.No further information was available at the time of this report.
Additional Manufacturer Narrative
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 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: 21541996
• Report Number: 2183816-2025-00011
• Device Sequence Number: 7099327
• Product Code: BYI
• UDI-Device Identifier: 00887761967366
• UDI-Public: (01)00887761967366(11)241113
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 03/06/2025

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: M08368
• Device Catalogue Number: PVAPX1HC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2024
• 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: Other
• Patient Sex: Unknown