TOTALCARE BARIATRIC PLUS BED

Additional Manufacturer Narrative

PER THE BAXTER USER MANUAL, WARNING: THE BED EXIT SYSTEM IS NOT INTENDED AS A SUBSTITUTE FOR GOOD NURSING PRACTICES. THE BED EX SYSTEM MUST BE USED IN CONJUNCTION WITH A SOUND RISK ASSESSMENT AND PROTOCOL. 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. UPON INSPECTION, BAXTER TECHNICIAN RAN A FUNCTION TEST ON THE TOTAL CARE BARIATRIC BED. THE BAXTER TECHNICIAN THOROUGHLY INSPECTED THE BED AND WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. THE BED FUNCTIONED AS DESIGNED. HOWEVER, IF THE REPORTED EVENT OF A TOTAL CARE BARIATRIC BED EXIT ALARM NOT WORKING WERE TO RECUR, IT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY, THEREFORE BAXTER CONSIDERS THIS EVENT REPORTABLE.

Description of Event or Problem

ON 12-JAN-2026, A COMPANY REPRESENTATIVE - SERVICE PERSONNEL CONTACTED TECHNICAL SERVICE TO REPORT THAT TOTALCARE BARIATRIC CAPITAL (PRODUCT CODE P1840DCA000051, SERIAL NUMBER (B)(6), PATIENT FELL OUT OF THE BED AND THE BED EXIT DID NOT ALARM. T HE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. IT WAS REPORTED NO PATIENT INJURIES OR MEDICAL INTERVENTION WITH THIS EVENT.