ENVELLA BED

Description of Event or Problem

BAXTER RECEIVED A REPORT THAT ENVELLA BED HAD POWER CORD DAMAGED WITH COPPER WIRES EXPOSED. THIS OCCURRED DURING BAXTER SERVICING/TESTING. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

THE BAXTER TECHNICIAN FOUND THE POWER CORD NEEDED TO BE REPLACED. 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. A SEARCH OF THE BAXTER MAINTENANCE RECORDS SHOWED BAXTER PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN JAN 16, 2026. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE POWER CORD TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.