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

Model Number	PVAPX1HC
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report that vest apx system new device had power cord damaged with copper wires exposed.This occurred at home during patient use.There was no patient injury or death reported with this event.
Additional Manufacturer Narrative
The baxter technical support found the power cord needed to be replaced.The vest airway clearance system is intended to help provide effective airway clearance.The unit has an inflatable vest garment attached by air hoses to an air pulse generator.The air pulse generator rapidly inflated and deflates the inflatable vest to gently compress and release the chest wall, creating airflow within the lungs.This process, mimics coughing, moves mucus toward the parge airways where it can be cleared by coughing or suctioning.A search of the baxter maintenance records did not show baxter performed any preventative maintenance on this product.It is unknown if the customer performs preventative maintenance on their products.A replacement power cord was sent to the customer.Based on this information, no further actions are required at this time.Although there was no reported injury with this event, if the report of a damaged power cord with exposed copper wires were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.

• 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: 25337379
• Report Number: 3008145987-2026-00039
• Device Sequence Number: 9920535
• Product Code: BYI
• UDI-Device Identifier: 00887761967243
• UDI-Public: (01)00887761967243
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K233441
• 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
• Report Date (Section B): 05/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: PVAPX1HC
• Device Catalogue Number: PVAPX1HC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown