COMPELLA BARIATRIC BED
Received Apr 25, 2025 · Event occurred Apr 5, 2025
Report 1824206-2025-00761 · MDR key 21910812
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 DRIVE LUG NUTS 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 NOV 30, 2024. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE CPR DRIVE LUG NUTS TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem
IT WAS REPORTED THAT COMPELLA RENT US SCALE PD PPM (PRODUCT CODE P7800ARENT01, SERIAL NUMBER (B)(6), HAD CPR FEATURE UNABLE TO BE ACTIVATED DUE TO PHYSICAL DAMAGE. THIS OCCURRED AFTER PATIENT USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.