inforMED
MalfunctionIOQ

TOTALCARE BARIATRIC PLUS BED

Received Aug 29, 2025 · Event occurred Aug 26, 2025

Report 1824206-2025-01495 · MDR key 22926903

Device

Generic name

Bed, Flotation Therapy, Powered

Model number

P1840B

Catalog number

P1840BTAP001

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 WAS STUCK. 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 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 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 HEAD OF BED WAS NOT LOWERING WHEN CPR WAS ACTIVATED. THE BED WAS LOCATED AT THE ACCOUNT AND OCCURRED BEFORE USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.