inforMED
MalfunctionIOQ

TOTALCAREBARIATRIC PLUS BED

Received Sep 23, 2025 · Event occurred May 14, 2025

Report 1824206-2025-01638 · MDR key 23123930

Device

Generic name

Bed, Flotation Therapy, Powered

Model number

P1840

Catalog number

P1840RE200

Lot number

N/A

Product problems

  • Activation Problem
  • Activation Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE BAXTER TECHNICIAN FOUND THE CPR VALVE NEEDED TO BE REPLACED. PER THE BAXTER SERVICE MANUAL THE TOTALCARE BARIATRIC BED AND TOTALCARE BED SYSTEM REQUIRES AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU PERFORM A SEMI-ANNUAL PREVENTATIVE MAINTENANCE. TEST THE CPR RELEASE FOR CORRECT OPERATION AND RESET OF THE HEAD CYLINDER. A SEARCH OF THE BAXTER MAINTENANCE RECORDS SHOWED BAXTER PERFORMED PREVENTIVE MAINTENANCE ON THIS BED ON APRIL 9, 2025. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE CPR VALVE TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

Description of Event or Problem

BAXTER RECEIVED A REPORT STATING THAT TOTALCARE BARIATRIC FRAME CPR FUNCTION WAS NOT ACTIVATED. THE BED WAS LOCATED AT THE ACCOUNT AND OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.