TOTALCARE BARIATRIC PLUS BED
Received May 12, 2025 · Event occurred Apr 25, 2025
Report 1824206-2025-00857 · MDR key 22006205
Device
Generic name
Bed, Flotation Therapy, Powered
Manufacturer
Baxter Healthcare CorporationModel number
P1840DCatalog number
P1840DRE0001
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
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 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 FROM A BAXTER TECHNICIAN TO REPORT THE TOTALCARE BARIATRIC RENTAL-NEW CPR CANNOT 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.