TOTALCARE BARIATRIC PLUS BED
Received May 27, 2026 · Event occurred May 6, 2026
Report 1824206-2026-01223 · MDR key 25311453
Device
Generic name
Bed, Flotation Therapy, Powered
Manufacturer
Baxter Healthcare CorporationModel number
P1840RCatalog number
P1840RE200
Lot number
N/A
Product problems
- Unintended Movement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UPON INSPECTION, BAXTER TECHNICIAN RAN A FUNCTION TEST ON THE BRAKES SYSTEM. PER THE BAXTER SERVICE MANUAL, THE TOTALCARE BARIATRIC BED AND TOTALCARE BARIATRIC PLUS THERAPY SYSTEM REQUIRE AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU PERFORM SEMIANNUAL PREVENTIVE MAINTENANCE (PM). PM WILL MINIMIZE DOWNTIME DUE TO EXCESSIVE WEAR. INSPECT THE CASTERS FOR PROPER MOUNTING, EXCESSIVE WEAR, OR TREAD DAMAGE. REPLACE AS NEEDED. VERIFY PROPER OPERATION OF THE BRAKE SYSTEM. ADJUST AS NECESSARY. A SEARCH OF THE BAXTER MAINTENANCE RECORDS SHOWED BAXTER PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN JAN 04, 2026. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS 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 BRAKES NOT HOLDING 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
BAXTER RECEIVED A REPORT THAT TC BARIATRIC PLUS W/ AIR HAD BRAKES NOT HOLDING. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.