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

Model Number	PVAPX1HC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	03/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced oxygen desaturation one day after the initial set up of the vest apx device.Patient has a tracheostomy and typically wears a trach collar on room air, with a baseline oxygen saturation of 95-99%.On march patient¿s oxygen saturation dropped to the high 80¿s with no medical intervention required.One day later, the patient¿s oxygen saturation dropped to 73%, patients¿ fingers and nails turned purple and patient was placed on 3l of oxygen, taking one hour to return to baseline.Currently patient saturation remains in the low 90's.Patient believes that this is caused by mucus blocking the airway, customer confirmed patient has suction equipment that can be use.The respiratory clinician provided education including the importance of effective airway clearance along with the risk of medical emergencies if mucus cannot be cleared.The device instructions for use warns users: ¿patients that may have difficulty clearing secretions from the upper airway may require specialized therapy in addition the vest apx system therapy.Please consult your physician to determine if additional therapy is appropriate.¿ there was no allegation of a device malfunction, and the device remains with the patient for continued use.No further information was available at the time of this report.
Additional Manufacturer Narrative
The exact cause of the reported event is undetermined; however, it is likely due to patient's extensive medical history, combined with ineffective airway clearance as noted by the patient.The respiratory clinician provided education including the importance of effective airway clearance along with the risk of medical emergencies if mucus cannot be cleared.Additionally, the respiratory clinician instructed the customer on pausing therapy to clear the airway when necessary and that some patients require specialized therapy in addition the vest device and advised reaching out to the patients¿ healthcare provider.There was no report of device malfunction, and the device remains with the patient who has continued use without any further oxygen desaturation episodes.Should additional relevant information become available, a supplemental report will be submitted.

• 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 SINGAPORE; 1 yishun avenue 7; singapore, north east 76892 3; SN 768923
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24985492
• Report Number: 3008145987-2026-00033
• Device Sequence Number: 10515097
• Product Code: BYI
• UDI-Device Identifier: 00887761967366
• UDI-Public: (01)00887761967366
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K233441
• 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): 04/24/2026

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: PVAPX1HC
• Device Catalogue Number: PVAPX1HC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male