TOTALCARE BED

Additional Manufacturer Narrative

UPON INSPECTION, BAXTER TECHNICIAN RAN A FUNCTION TEST ON THE HEAD SECTION. PER THE BAXTER SERVICE MANUAL THE TOTALCARE BED SYSTEM REQUIRES AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU PERFORM A SEMI-ANNUAL PREVENTATIVE MAINTENANCE. PREVENTATIVE MAINTENANCE WILL MINIMIZE DOWNTIME DUE TO EXCESSIVE WEAR. TEST THE HEAD SECTION SLIDE PIVOTS, SELF-LUBRICATING BEARING, AND SLIDER PIVOT EXTRUSIONS. LOOK FOR DAMAGE, AND MAKE SURE THE HEAD SECTION OPERATES CORRECTLY. REPLACE COMPONENTS AS NECESSARY. 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 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 HEAD SECTION NOT GOING UP 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 (B)(6) 2025, A OTHER HEALTH CARE PROFESSIONAL CONTACTED TECHNICAL SERVICE TO REPORT THAT TC BARIATRIC PLUS W/AIR & PULM PRODUCT CODE P1840RE300, (B)(6), HAD THE HEAD OF THE BED NOT RAISING. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.