ENVELLA BED
Received Jul 15, 2026 · Event occurred Jun 19, 2026
Report 1824206-2026-01593 · MDR key 25834062
Device
Generic name
Bed, Air Fluidized
Manufacturer
Baxter Healthcare CorporationModel number
P0819ACatalog number
P0819A
Product problems
- Unintended Movement
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
BAXTER RECEIVED A REPORT THAT THE ENVELLA BED HAD BRAKES NOT HOLDING WHILE IN BRAKE POSITION. THIS OCCURRED BEFORE USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Additional Manufacturer Narrative
INITIAL REPORTER POSTAL CODE: (b)(6).THE BAXTER TECHNICIAN FOUND THE CASTERS NEEDED TO BE REPLACED.A SEARCH OF THE BAXTER MAINTENANCE RECORDS SHOWED BAXTER PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN JANUARY 2026. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BEDPER THE BAXTER SERVICE MANUAL, IT IS NECESSARY FOR THE ENVELLA BED 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 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.THE TECHNICIAN REPLACED TWO FOOT CASTERS TO RESOLVE THE REPORTED EVENT.