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	09/30/2025
Type of Reportable Event	Malfunction
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.A replacement power cord 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.
Event or Problem Description
On 30-sep-2025, a customer contacted technical service to report that vest model 105 serviced (product code pr105, serial number (b)(6)), 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
H6 investigation findings and investigation conclusions: correction.Upon inspection, baxter technician ran a function test on the power cord.The baxter technician thoroughly inspected the power cord and was unable to duplicate the reported issue.The allegation of exposed copper was not was not confirmed.Outer insulation jacket was compromised but individual wire insulation was still intact.However, if the reported event of a power cord with exposed copper wires were to recur, it would be likely to cause or contribute to death or serious injury, therefore baxter considers this event reportable.

• 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: 23383326
• Report Number: 3008145987-2025-00016
• Device Sequence Number: 20062770
• Product Code: BYI
• UDI-Device Identifier: 00887761997776
• UDI-Public: (01)00887761997776
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2026

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: Lay User/Patient
• Device Model Number: PR105
• Device Catalogue Number: PR105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 06/09/2026
• 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.
• Patient Sex: Unknown