TOTALCARE BARIATRIC PLUS BED
Received Mar 26, 2025 · Event occurred Mar 16, 2025
Report 1824206-2025-00561 · MDR key 21699626
Device
Generic name
Bed, Flotation Therapy, Powered
Manufacturer
Baxter Healthcare CorporationModel number
P1840DCatalog number
P1840DRE0001
Product problems
- Unintended Movement
- Unintended Movement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT TOTALCARE BARIATRIC RENTAL-NEW (PRODUCT CODE P1840DRE0001, SERIAL NUMBER (B)(6)), HAD BRAKES NOT HOLDING. THIS OCCURRED DURING BAXTER SERVICING/TESTING. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.
Additional Manufacturer Narrative
THE BAXTER TECHNICIAN FOUND THE CASTERS NEEDED TO BE REPLACED. 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 (B)(6) 2025. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE CASTERS TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.