inforMED
MalfunctionIOQ

TOTALCARE BARIATRIC PLUS BED

Received Feb 26, 2026 · Event occurred Feb 2, 2026

Report 1824206-2026-00458 · MDR key 24463109

Device

Generic name

Bed, Flotation Therapy, Powered

Model number

P1840D

Catalog number

P1840DCA000010

Lot number

N/A

Product problems

  • Positioning Failure

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ON 02-FEB-2026, A COMPANY REPRESENTATIVE - SERVICE PERSONNEL CONTACTED TECHNICAL SERVICE TO REPORT THAT TOTALCARE BARIATRIC CAPITAL (PRODUCT CODE P1840DCA000010, SERIAL NUMBER (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.

Additional Manufacturer Narrative

THE BAXTER TECHNICIAN FOUND THE VALVE NEEDED TO BE REPLACED. 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 SHOWED BAXTER PERFORMED PREVENTIVE MAINTENANCE ON THIS BED ON APR 15, 2025. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE VALVE TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.