MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ENVELLA BED; BED, AIR FLUIDIZED

Model Number	P0819A
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative - service personnel contacted technical service to report that envella bed brakes were not holding.There was no patient/user injury, medical intervention, symptom, or adverse event reported.It was unknown if any second device was also involved.
Additional Manufacturer Narrative
The baxter technician found the brake casters needed to be replaced.Per the baxter service manual, it is necessary for the envella air fluidized therapy system to have an effective maintenance program.We recommend that you do annual preventive maintenance.Pm can help make sure of a long, operative life for the unit.Check that the brakes and steering operate correctly.Check that the casters are in good condition; they do not have cuts, are not worn, and have a good amount of tread.Repair or replace the part as applicable.A search of the baxter maintenance records did not show baxter performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician replaced the bake casters to resolve the reported event.Based on this information, no further action is required.

• Brand Name: ENVELLA BED
• Common Device Name: BED, AIR FLUIDIZED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 25108373
• Report Number: 1824206-2026-01005
• Device Sequence Number: 18464709
• Product Code: INX
• UDI-Device Identifier: 00887761013834
• UDI-Public: (01)00887761013834(11)170125
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 05/07/2026

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
• Device Model Number: P0819A
• Device Catalogue Number: P0819A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2017
• 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