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

Model Number	PR105
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating that vest model 105 power cord had damage with exposed copper wires.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
The vest airway clearance system, model 105 was developed to provide effective airway clearance therapy.The system consists of an inflatable garment attached to an air pulse generator that rapidly inflates and deflates the inflatable garment.This causes the chest wall to be gently compressed and released, which creates airflow within the lungs.This process moves the mucus toward the large airways where it can be cleared by coughing or suctioning.This type of airway clearance therapy is referred to as high frequency chest wall oscillation (hfcwo).Baxter has contacted the customer requesting the device to be returned for inspection.Customer has advised they had discarded the power cord; thus the device did not return to manufacture.A replacement power supply was sent to the customer to resolve the issue.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 wires were to recur, it could potentially cause serious injury or death.Therefore, baxter is reporting this event.

• Brand Name: THE VEST 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: 22470485
• Report Number: 3008145987-2025-00001
• Device Sequence Number: 8112990
• Product Code: BYI
• UDI-Device Identifier: 00887761997776
• UDI-Public: (01)00887761997776
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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: Lay User/Patient
• Device Model Number: PR105
• Device Catalogue Number: PR105
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 07/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Patient Sex: Unknown