ENVELLA BED
Received Jun 26, 2026 · Event occurred Jun 2, 2026
Report 1824206-2026-01458 · MDR key 25632634
Device
Generic name
Bed, Air Fluidized
Manufacturer
Baxter Healthcare CorporationModel number
P0819ACatalog number
P0819A
Product problems
- Unintended Movement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE BAXTER TECHNICIAN FOUND THE BRAKE CASTERS NEEDED TO BE REPLACED. PER THE BAXTER SERVICE MANUAL THE BED SHOULD BE SUBJECT TO AN EFFECTIVE MAINTENANCE PROGRAM. AN ANNUAL SERVICE OF THE BED IS ADVISED IN ORDER TO MAINTAIN ITS CHARACTERISTICS AND PERFORMANCE. BRAKE CASTERS SHOULD BE CHECKED FOR CUTS, WEAR AND QUALITY OF TREAD, ETC. AND REPLACED WHEN NECESSARY. APPLY THE BRAKE AND MAKE SURE THE BED DOES NOT MOVE. IF THERE IS MOVEMENT, LOOK AT THE BRAKE COMPONENTS FOR WEAR. LOOK AT THE STEER COMPONENTS FOR WEAR.ADJUST OR REPLACE COMPONENTS IF NECESSARY. A SEARCH OF THE BAXTER MAINTENANCE RECORDS SHOWED BAXTER PERFORMED PREVENTIVE MAINTENANCE ON THIS BED ON MAR 26, 2026. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE BRAKE CASTERS TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem
DURING SERVICING BY BAXTER, TECHNICAL SERVICE IDENTIFIED THAT ENVELLA BED BREAKS WERE NOT HOLDING. USER DEFINED DESCRIPTION:WAREHOUSE REPAIR. THIS OCCURRED DURING BAXTER SERVICING/TESTING. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.