inforMED
MalfunctionIOQ

TOTALCARE BARIATRIC PLUS BED

Received Oct 21, 2025 · Event occurred Sep 26, 2025

Report 1824206-2025-01833 · MDR key 23353557

Device

Generic name

Bed, Flotation Therapy, Powered

Model number

P1840D

Catalog number

P1840DCA000051

Lot number

NI

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

BAXTER RECEIVED A REPORT FROM A BAXTER TECHNICIAN TO REPORT THE TOTALCARE BARIATRIC CAPITAL BRAKE CASTERS WERE NOT HOLDING. THE BED WAS LOCATED AT THE ACCOUNT. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED. THERE WERE NO OTHER DEVICES REPORTED TO BE INVOLVED. THE CUSTOMER DID NOT COMMUNICATE THIS EVENT TO ANOTHER BAXTER DEPARTMENT OR AUTHORITY.

Additional Manufacturer Narrative

THE BAXTER TECHNICIAN FOUND THE CASTERS AND TORQUE TUBE 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 DID NOT SHOW BAXTER PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN REPLACED THE CASTERS AND TORQUE TUBE TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.