COMPELLA BARIATRIC BED

Description of Event or Problem

IT WAS REPORTED THAT COMPELLA CAP US SCALE PD PPM (PRODUCT CODE P7800A000001, SERIAL NUMBER (B)(6)), HAD CPR HANDLE DAMAGE UNABLE TO ACTIVATE THE CPR FUNCTION. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

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 JUL 22, 2019. 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.