inforMED
MalfunctionIOQ

TOTALCARE BARIATRIC PLUS BED

Received Mar 10, 2025 · Event occurred Feb 19, 2025

Report 1824206-2025-00466 · MDR key 21561422

Device

Generic name

Bed, Flotation Therapy, Powered

Model number

P1840D

Catalog number

P1840DRE0001

Lot number

N/A

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 STATING THAT TOTALCARE BARIATRIC FRAME BRAKE CASTERS WERE NOT HOLDING. THE BED WAS LOCATED AT THE ACCOUNT AND 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 BRAKE 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 PREVENTIVE MAINTENANCE ON THIS BED ON JULY 9, 2024. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE BRAKE CASTERS TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.