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

Model Number	P105
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pneumonia (2011)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned; therefore, a device analysis could not be completed.It was further reported no device malfunction occurred.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the vest apex system did not perform as intended.Reportedly the caregiver noticed since the patient began using the vest device the patient developed recurrent pneumonia (pna) infections.It usually takes approximately two weeks to develop pna symptoms; however, since the patient started on vest therapy the illness developed in 36 hours.The caregiver stated that the device is working as intended; however, ¿their mucus consolidated faster in the lungs and caused the patient to get sicker faster to a crisis point.¿ it was noted that when the patient was admitted to hospital on the date of the event, ¿they needed more support than usual, requiring high flow oxygen.¿ also noted, the patient stated that they also improved faster, as it usually takes them one week to recover, and in this case, it took them five days instead.There was no report of device malfunction reported.No further information was available at the time of this report.

• 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: 21931853
• Report Number: 2183816-2025-00022
• Device Sequence Number: 15616091
• Product Code: BYI
• UDI-Device Identifier: 00887761997776
• UDI-Public: (01)00887761997776
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2025

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: P105
• Device Catalogue Number: PVAPX1HC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/29/2025
• 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.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 13 YR
• Patient Sex: Female