P500 MRS CONTROL UNIT

Additional Manufacturer Narrative

THE BAXTER TECHNICIAN FOUND THE POWER CORD NEEDED TO BE REPLACED. IT IS NECESSARY FOR THE P500 TO HAVE AN EFFECTIVE MAINTENANCE PROGRAM. WE RECOMMEND THAT YOU DO ANNUAL PREVENTIVE MAINTENANCE (PM) AND TESTING FOR JOINT COMMISSION CERTIFICATION. PM AND TESTING NOT ONLY MEET JOINT COMMISSION REQUIREMENTS BUT CAN HELP MAKE SURE OF A LONG, OPERATIVE LIFE FOR THE P500. PM WILL MINIMIZE DOWNTIME DUE TO EXCESSIVE WEAR. EXAMINE THE PLUG FOR DAMAGE. MAKE SURE THE PLUG IS A ONE-PIECE MOLDED PLUG ASSEMBLY. IF IT IS NOT, REPLACE THE PLUG CORD ASSEMBLY. REPLACE ANY PLUG CORD ASSEMBLY THAT SHOWS ANY OF THESE: DISCOLORATION OF THE PLUG MOLDING AROUND THE PLUG BLADES; THIS COULD OCCUR IF THE PLUG BLADES HAVE OVERHEATED OR ARCED. ANY SIGNS OF CRACKING; THIS COULD OCCUR IF THE PLUG HAS BEEN BENT AND STRAIGHTENED TO A POINT PAST ITS USEFUL LIFE. LOOSE FIT OF THE PLUG BLADE (THE PLUG BLADE MOVES IN THE MOLDING); THIS COULD OCCUR IF THE MOLDING HAS OVERHEATED OR THE BLADES HAVE BEEN BENT AND STRAIGHTENED TO A POINT PAST THEIR USEFUL LIFE. REPLACE THE POWER CORD, IF DAMAGED. 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 POWER CORD TO RESOLVE THE REPORTED EVENT. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED

Description of Event or Problem

A COMPANY REPRESENTATIVE - SERVICE PERSONNEL CONTACTED TECHNICAL SERVICE TO REPORT THAT THE P500 MRS CONTROL UNIT POWER CORD WAS FRAYED WITH EXPOSED COPPER WIRES. THE PROCESS STEP DURING WHICH THIS OCCURRED WAS UNKNOWN. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED. THERE WERE NO OTHER DEVICES REPORTED TO BE INVOLVED.