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	05/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon inspection, baxter technician ran a function test on the envella bed.The baxter technician thoroughly inspected the envella bed and was unable to duplicate the reported issue.The envella bed functioned as designed.However, if the reported event of a power cord damaged with copper exposed were to recur, it would be likely to cause or contribute to death or serious injury, therefore baxter considers this event reportable.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.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.
Event or Problem Description
Baxter received a report that envella bed had power cord damaged with copper wires exposed.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: 25336745
• Report Number: 1824206-2026-01247
• Device Sequence Number: 9806241
• Product Code: INX
• UDI-Device Identifier: 00887761013834
• UDI-Public: (01)00887761013834(11)190118
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/29/2026

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: 05/04/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2019
• 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