COMPELLA BARIATRIC BED
Received Jul 17, 2025 · Event occurred Jul 9, 2025
Report 1824206-2025-01272 · MDR key 22534783
Device
Generic name
Bed, Flotation Therapy, Powered
Manufacturer
Baxter Healthcare CorporationModel number
P7800ACatalog number
P7800ARENT01
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 MOUNT BRAKE NEEDED TO BE REPLACED. PER THE BAXTER SERVICE MANUAL THE COMPELLA BED REQUIRES AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU PERFORM ANNUAL PREVENTATIVE MAINTENANCE. PAY PARTICULAR ATTENTION TO SAFETY FEATURES, WHICH INCLUDE BUT ARE NOT LIMITED TO: ALL CAREGIVER AND PATIENT CONTROLS, ALONG WITH THEIR INDICATORS, OPERATE CORRECTLY; THIS INCLUDES CONTROLS FOR CPR. REPLACE OR REPAIR PARTS AS NECESSARY. A SEARCH OF THE BAXTER MAINTENANCE RECORDS SHOWED BAXTER PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN MAR 4, 2025. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE CPR MOUNT BRAKE TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem
DURING SERVICING BY BAXTER, TECHNICAL SERVICE IDENTIFIED THAT COMPELLA RENT US SCALE PD PPM (PRODUCT CODE P7800ARENT01, SERIAL NUMBER (B)(6)), HAD CPR HANDLE BROKEN NOT ACTIVATING THE FEATURE. THIS OCCURRED DURING BAXTER SERVICING/TESTING. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.