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

Model Number	P105000BT
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned; therefore, a device analysis could not be completed.The exact cause of the event and alleged water in the device tubing is unknown, as the customer is refusing to return the vest device and its components.The cause of the event is likely multifactorial due to the patient¿s complex pulmonary medical history combined with the delay in therapy likely due to insurance/financial issues the customer needed to resolve.At this time, use error or malfunction cannot be ruled out as the device is not being returned for inspection.However, prevention of this type of event (protection against water in device tubing) is outlined in the device instructions for use.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It is reported the patient has retained secretions and it is noted that the patient is scheduled for a bronchoscope dilation/cleanout procedure as a result of the patient¿s lack of access to vest therapy during the delay in device replacement.Customer initially contacted baxter respiratory customer support on foury nine days from this report to request a replacement of the vest after reporting that water was present in the device tubing.At the time of this initial contact, there was no allegation of patient injury.Baxter respiratory customer support advised the patient not to use the device due to the presence of water.An exchange of the vest device was initiated the next day, involving baxter and the patient¿s prescribing physician; however, the exchange could not be completed due to the patient¿s insurance and/or financial obligations.The customer reported concerns that the patient subsequently developed increased retained respiratory secretions and is scheduled to undergo a bronchoscopy procedure for airway dilation and secretion clearance.The customer believes this condition resulted from the patient¿s lack of access to vest therapy during the delay in device replacement.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 ; 2242705355
• MDR Report Key: 24946147
• Report Number: 3008145987-2026-00030
• Device Sequence Number: 12072527
• Product Code: BYI
• UDI-Device Identifier: 00887761997776
• UDI-Public: (01)00887761997776(11)231129
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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: P105000BT
• Device Catalogue Number: P105000BT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/21/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male