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

Model Number	P105BYA
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technical support representative performed troubleshooting over the phone with the account, asking the account to replace the power cord.Upon troubleshooting, it was determined that the power cord was damaged with exposed copper wires.Account discarded the faulty power cord and a replacement of the 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 wires were to recur, it could potentially cause serious injury or death.Therefore baxter is reporting this event.
Event or Problem Description
Baxter received a report stating that vest 105 power cord was frayed with exposed copper wires.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• 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: 21514335
• Report Number: 2183816-2025-00010
• Device Sequence Number: 20838271
• Product Code: BYI
• UDI-Device Identifier: 00887761997745
• UDI-Public: (01)00887761997745
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2025

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: Health Professional
• Device Model Number: P105BYA
• Device Catalogue Number: P105BYA
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown