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

Model Number	P105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Granuloma (1876)
Date of Event	02/23/2025
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 experienced a medical condition in conjunction with a vest system.The patient experienced redness and irritation around the percutaneous endoscopic gastrostomy (peg/mickey) site.Upon further examination, granulation was observed around the mickey site.The area was treated with antibiotic cream, silver nitrate triple antibiotic ointment, and hydrocortisone.There was no report of device malfunction, and the device remains with the patient for continued use.An in-home patient visit by a respiratory clinician is planned to review therapy, garment fit, and foam cushioning use.No further information was available at the time of this report.
Additional Manufacturer Narrative
Additional information: h6 and h11.H11: a service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: THE VEST 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: 22069708
• Report Number: 2183816-2025-00027
• Device Sequence Number: 8702432
• Product Code: BYI
• UDI-Device Identifier: 00887761997776
• UDI-Public: (01)00887761997776
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 06/23/2025

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: P105
• Device Catalogue Number: P105BYWAR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 28 YR
• Patient Sex: Male