inforMED
MalfunctionIOQ

TOTALCARE BARIATRIC PLUS BED

Received Sep 17, 2025 · Event occurred Aug 25, 2025

Report 1824206-2025-01606 · MDR key 23074539

Device

Generic name

Bed, Flotation Therapy, Powered

Model number

P1840RE

Catalog number

P1840RE200

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 TC BARIATRIC PLUS W/ AIR BRAKE CASTERS WERE NOT HOLDING; BRAKE SYSTEM IS ENGAGED, BUT IF HEAVY PRESSURE IS APPLIED, THE BED WILL MOVE. THE BED WAS LOCATED AT THE ACCOUNT. THIS OCCURRED DURING PATIENT USE. 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 NO PROBLEM. 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 CUSTOMER DID NOT WANT A SWAP, BUT ONLY WANTED O MAKE BAXTER AWARE. THE BAXTER TECHNICIAN INSPECTED THE DEVICE AND FOUND NO PROBLEM. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED. IF ANY FURTHER INFORMATION IS RECEIVED, THE RECORD WILL BE REASSESSED ACCORDINGLY.