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	Vitreous Detachment (2445)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: the date of the event was reported as "around (b)(6) 2025".Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a patient sustained an eye injury coincident with use of the vest apx system.The patient had left eye cataract surgery in the summer of 2025 which took a prolonged time to recover due to delayed healing.The patient suspended use of the vest for approximately two weeks after surgery.The patient reportedly did not consult their eye doctor/surgeon regarding use of the vest device prior to or following the cataract surgery.The patient resumed use of the vest sixteen days post operatively.Approximately two days after resuming use of the vest the patient developed a ¿floater¿ in their left eye.After an unspecified amount of time, the patient followed up with their eye doctor who informed them that they had a ¿ruptured water sac which causes a permanent floater¿.The patient reported ¿if i turn certain directions, i can see the water sac¿.There was no report of a device malfunction.No further information was available at the time of this report.
Additional Manufacturer Narrative
The device was not returned since the patient remains with the device; therefore, a device analysis could not be completed.The dhr was reviewed and no manufacturing issues were identified, and no abnormalities were found in the record.There were no in-process failures, and no rework or repair was performed on this device.

• 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: 24474329
• Report Number: 3008145987-2026-00017
• Device Sequence Number: 13172773
• Product Code: BYI
• UDI-Device Identifier: 00887761967366
• UDI-Public: (01)00887761967366(11)990107
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/21/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/1999
• 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: Disability
• Patient Age: 76 YR
• Patient Sex: Female