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

Model Number	P0819A
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report stating that envella bed brake casters were not holding.This occurred during patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
The baxter technician found the power cord 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 power cord is in good condition: the plug is a one-piece molded plug assembly, the assembly shows no signs of cracking, the plug molding around the blade is not discolored, and the blade is tight in the molding.The power cord hooks show no sign of cracking and are intact with no damage.The power cord strain relief shows no sign of cracking and is intact with no damage.Repair or replace the part as applicable.A search of baxter maintenance records showed baxter performed preventive maintenance on this bed in may, 2026.It is unknown if the facility performed any other preventive maintenance on this bed.The technician replaced the power cord 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 ; +1(224)270-5355
• MDR Report Key: 50182077
• Report Number: 1824206-2026-01847
• Device Sequence Number: 13233233
• Product Code: INX
• UDI-Device Identifier: 00887761013834
• UDI-Public: (01)00887761013834(11)170511
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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
• Operator of Device: Other
• Device Model Number: P0819A
• Device Catalogue Number: P0819A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2017
• 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