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

Model Number	M08368
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Twiddlers Syndrome (4563)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device will not be returned; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a patient utilizing a vest apx system sustained a shift in their pacemaker device.Reportedly the vest shook the patient ¿so bad¿ that it moved the patient¿s implanted, unstitched pacemaker device two inches to the left.This caused the patient¿s heart rate to lower (rate unknown).The patient required surgery to repair the pacemaker.There was no allegation of a device malfunction, and the device is not being returned.The patient¿s healthcare provider advised the patient to resume therapy 6-weeks post recent procedure.An in-home patient follow-up visit is planned upon the patient¿s clearance to resume therapy, for confirmation of device setting, and garment fit.No further information was available at the time of this report.

• 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 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: 22675379
• Report Number: 2183816-2025-00045
• Device Sequence Number: 15869021
• Product Code: BYI
• UDI-Device Identifier: 00887761967366
• UDI-Public: (01)00887761967366(11)241008
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 07/31/2025

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: Other
• Device Model Number: M08368
• Device Catalogue Number: PVAPX1HC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male