TOTALCARE BARIATRIC PLUS BED

Additional Manufacturer Narrative

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. NO FURTHER INFORMATION IS AVAILABLE ON THE REPAIR OF THE BED AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADDITIONAL RELEVANT INFORMATION WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

ON (B)(6) 2026, A OTHER HEALTH CARE PROFESSIONAL CONTACTED TECHNICAL SERVICE TO REPORT THAT TOTALCARE BARIATRIC CAPITAL (PRODUCT CODE P1840DCA000010, SERIAL NUMBER (B)(6)), HAD HEAD SECTION DOESN'T RAISE. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.