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

Model Number	P0819A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6) attn accounts payable.The baxter technician found the drive lug broken and 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).Pm can help make sure of a long, operative life for the unit.Check that the all caregiver and patient controls, along with their indicators, operate correctly; this includes controls for bed articulation, scale, bed exit, surface functions, cpr, pendant controls, foot control, etc.Repair or replace the part as applicable.A search of the baxter maintenance records showed baxter performed preventative maintenance on this bed in mar 9, 2026.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the drive lugs to resolve the reported event.Based on this information, no further action is required.
Event or Problem Description
Baxter received a report that envella bed had cpr not working on either side of bed.This occurred during patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• 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: 24772270
• Report Number: 1824206-2026-00763
• Device Sequence Number: 6065949
• Product Code: INX
• UDI-Device Identifier: 00887761013834
• UDI-Public: (01)00887761013834(11)170914
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

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
• Operator of Device: Other
• Device Model Number: P0819A
• Device Catalogue Number: P0819A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/14/2017
• 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