inforMED
MalfunctionINX

ENVELLA BED

Received Jun 26, 2026 · Event occurred Jun 2, 2026

Report 1824206-2026-01458 · MDR key 25632634

Device

Generic name

Bed, Air Fluidized

Model number

P0819A

Catalog 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.