COMPELLA BARIATRIC BED
Received May 16, 2025 · Event occurred May 1, 2025
Report 1824206-2025-00892 · MDR key 22037873
Device
Generic name
Bed, Flotation Therapy, Powered
Manufacturer
Baxter Healthcare CorporationModel number
P7800ACatalog number
P7800A000037
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 HANDLE 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 OCT 2, 2024. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE CPR HANDLE TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem
IT WAS REPORTED THAT COMPELLA FRAME (PRODUCT CODE P7800A000037, SERIAL NUMBER (B)(6)), HAD CPR FEATURE UNABLE TO BE ACTIVATED. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.