ENVELLA BED

Additional Manufacturer Narrative

THE BAXTER TECHNICIAN FOUND THE CPR CABLE 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 ALL CAREGIVER AND PATIENT CONTROLS, ALONG WITH THEIR INDICATORS, OPERATE CORRECTLY; THIS INCLUDES CONTROLS FOR BED ARTICULATION, SCALE, BED EXIT, SURFACE FUNCTIONS, CPR, PENDANT CONTROLS, FOOT CONTROL, ETC. REPAIR OR REPLACE THE PART AS APPLICABLE. A SEARCH OF THE BAXTER MAINTENANCE RECORDS SHOWED BAXTER PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN JUL 02, 2025. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE CPR CABLE TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem

BAXTER RECEIVED A REPORT THAT ENVELLA BED HAD CPR FUNCTION NOT WORKING. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.