TOTALCARE BARIATRIC PLUS BED
Received Mar 28, 2025 · Event occurred Mar 12, 2025
Report 1824206-2025-00583 · MDR key 21720434
Device
Generic name
Bed, Flotation Therapy, Powered
Manufacturer
Baxter Healthcare CorporationModel number
P1840DCatalog number
P1840DCA000010
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 SOLENOID 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 JULY 13, 2024. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE CPR SOLENOID 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 SECTION WAS UNABLE TO LOWER WHEN THE CPR WAS ACTIVATED. THE BED WAS LOCATED AT THE ACCOUNT AND OCCURRED AFTER PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.