AMPLION CARE ASSURANCE

Description of Event or Problem

COMPLAINT NARRATIVE: A SITE REPRESENTATIVE REPORTED NO LEDS ON A PATIENT STATION (PAS) IN (B)(6), A PRIVATE ROOM, DISCOVERED DURING A DEVICE FUNCTIONALITY AUDIT. NO PATIENT WAS ASSIGNED TO THE ROOM AT THE TIME THE COMPLAINT TICKET WAS SUBMITTED. COMPLAINT TROUBLESHOOTING: AMPLION SUPPORT ASKED THE SITE REPRESENTATIVE TO PRESS FIRST THE STAT ASSIST BUTTON AND THEN THE CODE BLUE BUTTON. EACH BUTTON PRESS DID NOT GENERATE SMART ROOM CONTROLLER (SRC) LOG ACTIVITY. (THE SRC IS AN EMBEDDED COMPUTER BASED DEVICE, THAT CONTROLS NURSE CALL DEVICES IN A ROOM). AMPLION SUPPORT RESTARTED THE ROOM (I.E., RESTARTED THE SERVICE THAT CONTROLS THE SOFTWARE CONNECTED TO THE ROOM'S DEVICES), AND VERIFIED THE PAS WAS CONNECTED TO THE ROOM. ALL TROUBLESHOOTING INDICATED THE PAS WAS LIKELY EXPERIENCING A KEYPAD FAILURE FOR BOTH LEDS AND BUTTONS. COMPLAINT RESOLUTION: AMPLION SUPPORT REQUESTED REPLACEMENT OF THE PAS. THE SITE REPRESENTATIVE REPLACED THE PAS. AMPLION SUPPORT, WORKING WITH THE SITE REPRESENTATIVE TESTED AND VERIFIED FULL FUNCTIONALITY OF THE REPLACEMENT PAS. FAILURE ANALYSIS: THE RETURNED PAS WAS SUBMITTED TO FAILURE ANALYSIS (FA) TESTING AND FAILED. FA TESTING INDICATED DAMAGED (BURNT/SHORTED) LEADS/TRACES IN THE FLAT FLEXIBLE CABLE (FFC) WITH TOTAL KEYPAD FAILURE. DAMAGE TO THE TRACES OF THE FFC CAN CAUSE LOSS OF FUNCTIONALITY TO ONE OR MORE KEYPAD BUTTONS OR LEDS. THIS DAMAGE IS OFTEN CAUSED BY IMPROPER CLEANING PRACTICES, RESULTING IN LIQUIDS/CLEANING AGENTS GETTING UNDER THE DEVICE'S KEYPAD OVERLAY.