TOTALCARE BARIATRIC PLUS BED

Additional Manufacturer Narrative

THE BAXTER TECHNICIAN FOUND THE CPR VALVE NEEDED TO BE REPLACED. PER THE BAXTER SERVICE MANUAL THE TOTALCARE BARIATRIC BED AND TOTALCARE BED SYSTEM REQUIRES AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU PERFORM A SEMI-ANNUAL PREVENTATIVE MAINTENANCE. TEST THE CPR RELEASE FOR CORRECT OPERATION AND RESET OF THE HEAD CYLINDER. A SEARCH OF THE BAXTER MAINTENANCE RECORDS DID NOT SHOW BAXTER PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN REPLACED THE CPR VALVE TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem

ON (B)(6) 2025, A CUSTOMER CONTACTED TECHNICAL SERVICE TO REPORT THAT TOTALCARE BARIATRIC CAPITAL (PRODUCT CODE P1840DCA000026, SERIAL NUMBER (B)(6)), HAD CPR FEATURE NOT FUNCTIONING WHEN PEDAL ENGAGED. THIS OCCURRED AFTER PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.