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

Model Number	P0819A
Medical Device Problem Codes	No Audible Alarm (1019); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report that envella bed had bed exit alarm not working.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
The investigation is ongoing, however if any additional relevant information is identified following the completion of the investigation, the additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Additional Manufacturer Narrative
Upon inspection, baxter technician ran a function test on the envella bed.The baxter technician thoroughly inspected the bed and was unable to duplicate the reported issue, the reported issue was caused due to the staff activated the bed exit alarm prior to the patient getting into the bed which caused the alarm to not function properly.However, if the reported event of bed exit alarm not working, 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 showed baxter performed preventative maintenance on this bed in sep 03, 2025.It is unknown if the facility performed any other preventative maintenance on this bed.The account will replace the bed no further action needed.

• 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: 25460978
• Report Number: 1824206-2026-01327
• Device Sequence Number: 10363514
• Product Code: INX
• UDI-Device Identifier: 00887761013834
• UDI-Public: (01)00887761013834(11)170308
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 06/16/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Supplement Date Received by Manufacturer: 06/11/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2017
• 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