inforMED
MalfunctionIOQ

TOTALCARE BARIATRIC PLUS BED

Received Apr 14, 2025 · Event occurred Mar 21, 2025

Report 1824206-2025-00689 · MDR key 21835335

Device

Generic name

Bed, Flotation Therapy, Powered

Model number

P1840D

Catalog number

P1840DCA000010

Lot number

NI

Product problems

  • Activation Problem
  • Activation Problem

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 TOTAL CARE BARIATRIC CAPITAL CPR WAS NOT ABLE TO BE ACTIVATED. THE BED WAS LOCATED AT THE ACCOUNT. THIS OCCURRED DURING BAXTER SERVICING/TESTING. 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 CPR VALVE NEEDED TO BE REPLACED. PER THE BAXTER SERVICE MANUAL THE TOTAL CARE BARIATRIC BED AND TOTAL CARE 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.