AMPLION CARE ASSURANCE

Description of Event or Problem

COMPLAINT NARRATIVE: A SITE REPRESENTATIVE REPORTED THE CODE BLUE BUTTON DID NOT ACTIVATE WHEN PRESSED ON THE PATIENT STATION (PAS) IN ROOM (B)(6). THE SITE REPRESENTATIVE REPORTED THAT THE ISSUE WAS DISCOVERED DURING TESTING OF THE PAS AND WAS NOT RELATED TO A PATIENT IN DISTRESS. COMPLAINT TROUBLESHOOTING: AMPLION SUPPORT BEGAN TROUBLESHOOTING THE ISSUE IN COORDINATION WITH THE SITE JUST OVER 1 HOUR AFTER THE COMPLAINT WAS SUBMITTED. AMPLION SUPPORT REVIEWED SMART ROOM CONTROLLER (SRC) LOGS FOR ROOM (B)(6), WHICH INDICATED THAT THE SYSTEM DID NOT REGISTER ANY DEVICES CONNECTED TO THE SRC FOR THE ROOM. (THE SRC IS AN EMBEDDED COMPUTER-BASED DEVICE THAT CONTROLS THE NURSE CALL DEVICES IN THE ROOM). FOR THIS REASON, TROUBLESHOOTING MOVED FROM THE PAS TO THE SRC AS THE POSSIBLE SOURCE OF THE ISSUE. AMPLION SUPPORT RESTARTED THE ROOM (I.E., RESTARTED THE SERVICE THAT CONTROLS THE SOFTWARE CONNECTED TO THE ROOM'S DEVICES) AND NO DEVICES REGISTERED IN THE SYSTEM. AMPLION SUPPORT THEN POWER-CYCLED THE SRC (I.E., TURNED THE SRC OFF AND THEN BACK ON) AND NO DEVICES REGISTERED IN THE SYSTEM. AMPLION SUPPORT CONTINUED TO TROUBLESHOOT THE SRC, REQUESTING THE SITE REPRESENTATIVE TAKE THE FOLLOWING ACTIONS RELATED TO THE SRC: 1. UNPLUG ALL DEVICE CABLES AND POWER CABLE (POE CABLE) FROM THE SRC. THEN, WITH ALL DEVICES UNPLUGGED, PLUG ONLY THE POE CABLE BACK INTO THE SRC. RESULT: WITH ONLY THE POWER SUPPLY AND NO DEVICES PLUGGED INTO THE SRC, THE PIB (WHICH IS THE PART OF THE SRC WHERE AMPLION IN-ROOM DEVICES CONNECT) CONTINUED TO FAIL TO REGISTER IN THE SYSTEM. 2. PLUG ONLY ONE DEVICE CABLE BACK INTO THE SRC, FOLLOWED BY AMPLION SUPPORT RESTARTING THE ROOM. RESULT: NEITHER THE PIB, NOR ANY DEVICES REGISTERED IN THE SYSTEM. 3. UNPLUG THE DEVICE CABLE THAT WAS JUST PLUGGED IN AND PLUG IN A DIFFERENT DEVICE CABLE, FOLLOWED BY AMPLION SUPPORT AGAIN RESTARTING THE ROOM. RESULT: NEITHER THE PIB, NOR ANY DEVICES REGISTERED IN THE SYSTEM. 4. UNPLUG THE DEVICE CABLE THAT WAS JUST PLUGGED IN AND PLUG IN THE LAST DEVICE CABLE THAT HAD NOT YET BEEN UTILIZED DURING TROUBLESHOOTING, FOLLOWED BY AMPLION SUPPORT AGAIN RESTARTING THE ROOM. RESULT: NEITHER THE PIB, NOR ANY DEVICES REGISTERED IN THE SYSTEM. BASED UPON THE TROUBLESHOOTING RESULTS, THE FAILURE OF THE PAS CODE BLUE BUTTON TO ACTIVATE APPEARED TO BE RELATED TO A FAILURE OF THE ROOM (B)(6) SRC. COMPLAINT RESOLUTION: AMPLION SUPPORT RECOMMENDED REPLACEMENT OF THE SRC IN ROOM (B)(6). ONCE THE NEW SRC WAS INSTALLED, AMPLION SUPPORT UPDATED THE SRC (IP ADDRESS, EXTENSION IN BARESIP AND FIRMWARE). UPON COMPLETION OF THE SRC UPDATES, AMPLION SUPPORT COORDINATED WITH THE SITE REPRESENTATIVE TO VERIFY FULL FUNCTIONALITY OF THE AMPLION DEVICES IN ROOM (B)(6). AMPLION SUPPORT RESTARTED THE ROOM. ALL DEVICES REGISTERED IN THE SYSTEM EXCEPT THE RIDSECONDARY (I.E., A CLINICAL DEVICE INPUT STATION [CDIS], WHICH IS ONE OF THE AMPLION IN-ROOM DEVICES THAT CONNECTS TO THE SRC). THE SITE REPRESENTATIVE WAS ASKED TO CHECK WHETHER EITHER OF THE ROOM'S CDIS DEVICES HAD A BLUE FLASHING LIGHT. THE SITE REPRESENTATIVE CONFIRMED THAT THE CDIS WITH THE VENT/PAD/BIPAP BUTTONS HAD A BLUE FLASHING LIGHT GOING ACROSS THE TOP. AMPLION SUPPORT REMOTELY SUPPORTED THE SITE REPRESENTATIVE IN UPDATING THE FIRMWARE ON THE AFFECTED CDIS. AMPLION SUPPORT AGAIN RESTARTED THE ROOM. AFTER THIS RESTART, NEITHER THE RID NOR THE RIDSECONDARY REGISTERED IN THE SYSTEM. THE SITE REPRESENTATIVE REPORTED THAT NEITHER OF THE CDIS DEVICES HAD A BLUE FLASHING LIGHT GOING ACROSS THE TOP. AMPLION SUPPORT ASKED THE SITE REPRESENTATIVE TO CHECK THE DIP (DUAL INLINE PACKAGE) SWITCH POSITIONS ON THE CDIS WITH THE BED/PULSE OX/IV BUTTONS AND UPDATE THEM TO UD (I.E., LEFT DIP SWITCH UP AND RIGHT DIP SWITCH DOWN). AMPLION SUPPORT RESTARTED THE ROOM ONCE MORE AND ALL DEVICES REGISTERED IN THE SYSTEM SUCCESSFULLY. AMPLION SUPPORT ASKED THE SITE REPRESENTATIVE TO TEST THE CODE BLUE ALARM. THE SITE REPRESENTATIVE PRESSED THE CODE BLUE BUTTON ON THE PAS. SRC LOGS INDICATED ACTIVATION OF THE ALARM. THE SITE REPRESENTATIVE PRESSED THE CODE BLUE BUTTON ON THE PAS AGAIN. SRC LOGS INDICATED THE ALARM CLEARED. REPLACEMENT OF THE ROOM (B)(6) SRC RESOLVED THE COMPLAINT. FAILURE ANALYSIS: AMPLION SUPPORT PERSONNEL REQUESTED THAT THE SRC REMOVED FROM ROOM (B)(6) BE RETURNED TO AMPLION FOR FAILURE ANALYSIS. THE PRODUCT HAS OT BEEN RETURNED BY THE CUSTOMER AS OF THE DATE OF THIS REPORT.