inforMED
MalfunctionIOQ

TOTALCARE BARIATRIC PLUS BED

Received Mar 2, 2026 · Event occurred Feb 4, 2026

Report 1824206-2026-00476 · MDR key 24484609

Device

Generic name

Bed, Flotation Therapy, Powered

Model number

P1840R

Catalog number

P1840RE200

Lot number

N/A

Product problems

  • Positioning Failure

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

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 PREVENTATIVE MAINTENANCE ON THIS BED IN FEB 1, 2026. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE VALVE TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem

ON (B)(6) 2026, A NURSE CONTACTED TECHNICAL SERVICE TO REPORT THAT TC BARIATRIC PLUS W/ AIR (PRODUCT CODE P1840RE200, SERIAL NUMBER (B)(6), HAD HEAD NOT RAISING. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.