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	Unspecified Gastrointestinal Problem (4491)
Date of Event	04/10/2025
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¿s gastrostomy tube (g-tube) ¿fell out¿ after removing the vest apx system.After the vest and the patient¿s clothes were removed, the g-tube ¿feel onto the floor.¿ the patient went to the emergency room where they received unspecified ¿treatment.¿ the following day the patient underwent an ¿outpatient procedure¿ to have the g-tube reinserted.The patient was discharged that same day.There was no report of a device malfunction.The vest will remain with the patient as they plan to return to using the vest.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 ; 2242702068
• MDR Report Key: 22983910
• Report Number: 3008145987-2025-00010
• Device Sequence Number: 8938035
• Product Code: BYI
• UDI-Device Identifier: 00887761967366
• UDI-Public: (01)00887761967366(11)990113
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• 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): 09/05/2025

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?: Yes
• 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: 08/08/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/1999
• 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; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female