AMPLION CARE ASSURANCE
Received Sep 28, 2023 · Event occurred Sep 7, 2023
Report 3009164985-2023-00019 · MDR key 17834879
Device
Generic name
Patient Station
Manufacturer
Amplion Clinical Communications, Inc.Model number
D-PAS-12-1Catalog number
D-PAS-12-1
Lot number
PO 7051 PS011 060616
Product problems
- Key or Button Unresponsive/not Working
- Key or Button Unresponsive/not Working
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
COMPLAINT NARRATIVE NOTE: THE SITE REPRESENTATIVE REPORTED SEVERAL DIFFERENT ROOM NUMBERS IN ERROR THROUGHOUT HIS INTERACTIONS WITH AMPLION SUPPORT. ROOM 3150 WAS INITIALLY REPORTED AS THE ROOM AT ISSUE, THEN THE SITE REPRESENTATIVE STATED THAT IT WAS ACTUALLY ROOM 3139, AND LASTLY, HE STATED THE ACTUAL ROOM WITH THE ISSUE WAS ROOM 3149. THIS NARRATIVE EXPLANATION WILL STATE THE NUMBER FOR THE ROOM THAT WAS PROVIDED BY THE SITE REPRESENTATIVE AT THE TIME OF EACH STEP IN THE PROCESS FOLLOWED BY "[ROOM 3149]" TO REFLECT THAT IT IS UNDERSTOOD BY AMPLION, BASED UPON WHAT WAS COMMUNICATED FROM THE SITE REPRESENTATIVE, THAT ALL STEPS WERE ACTUALLY RELATED TO THE PAS IN A SINGLE ROOM (3149). AS NO AMPLION PERSONNEL WERE ON SITE DURING THE TROUBLESHOOTING PROCESS, AMPLION IS RELYING ON THE WORD OF THE SITE REPRESENTATIVE THAT THE ISSUE DISCUSSED IN THIS REPORT WAS ISOLATED TO A SINGLE DEVICE AND ALL STEPS TAKEN OCCURRED IN A SINGLE ROOM (3149). A SITE REPRESENTATIVE INITIALLY REPORTED THAT THE CODE BLUE BUTTON WAS NOT WORKING ON THE PATIENT STATION (PAS) IN ROOM 3150 [ROOM 3149]. 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 COORDINATED WITH THE SITE REPRESENTATIVE TO TEST THE PAS IN ROOM 3150 [ROOM 3149] WITHIN AN HOUR OF RECEIVING THE COMPLAINT. NOTE: THE SITE REPRESENTATIVE STATED HE WOULD NEED TO GO TO THE ROOM AND WOULD CALL AMPLION SUPPORT BACK. WHEN HE CALLED BACK, HE STATED THAT HE HAD REPORTED THE WRONG ROOM NUMBER INITIALLY AND CLARIFIED THAT HE WAS REFERRING TO ROOM 3139 [ROOM 3149]. AMPLION SUPPORT REQUESTED THE SITE REPRESENTATIVE PRESS THE CODE BLUE BUTTON ON THE PAS. AMPLION SUPPORT DID NOT OBSERVE SMART ROOM CONTROLLER (SRC) LOG ACTIVITY RELATED TO THE BUTTON PRESS. (THE SRC IS AN EMBEDDED COMPUTER-BASED DEVICE, THAT CONTROLS NURSE CALL DEVICES IN A ROOM). NOTE: THE SRC LOG BEING MONITORED BY AMPLION DURING INITIAL TROUBLESHOOTING WAS FOR ROOM 3139, WHICH WAS THE ROOM NUMBER REPORTED AT THE TIME, AND SHOWED NO ACTIVITY. BASED UPON THE ROOM NUMBER BEING INCORRECTLY REPORTED, AND THE TEST BUTTON PRESSES BEING IN ANOTHER ROOM, THIS LACK OF LOG ACTIVITY IS EXPECTED. AS PART OF THIS COMPLAINT INVESTIGATION, BEARING IN MIND THE IMPACTED ROOM LATER REPORTED AS ROOM 3149, AMPLION REVIEWED THE SRC LOG FOR ROOM 3149 FOR THE TIME OF TROUBLESHOOTING, WHICH ALSO SHOWED NO ACTIVITY RELATED TO THE CODE BLUE BUTTON PRESS. BECAUSE ROOM 3149 WAS THE IMPACTED ROOM, THE LACK OF SRC LOG ACTIVITY IN THIS ROOM INDICATES A POTENTIAL FAILURE. WHEN ASKED BY AMPLION SUPPORT IF LEDS WERE VISIBLE ON THE PAS, THE SITE REPRESENTATIVE REPORTED THERE WERE NO LEDS ILLUMINATED. BASED ON TROUBLESHOOTING RESULTS, AMPLION SUPPORT NOTED A POTENTIAL KEYPAD FAILURE FOR THE PAS. COMPLAINT RESOLUTION AMPLION SUPPORT RECOMMENDED REPLACEMENT OF THE PAS IN ROOM 3139 [ROOM 3149]. THE SITE REPRESENTATIVE COMMITTED TO REPLACING THE PAS AND CALLING AMPLION SUPPORT WHEN COMPLETE. WHEN AMPLION SUPPORT SPOKE WITH THE SITE REPRESENTATIVE AFTER THE PAS WAS REPLACED, THE SITE REPRESENTATIVE REPORTED THAT HE HAD REPLACED THE PAS IN ROOM 3149. AMPLION SUPPORT ASKED THE SITE REPRESENTATIVE IF HE MEANT TO REPORT THE REPLACEMENT OF THE PAS IN ROOM 3139 AND THE SITE REPRESENTATIVE STATED THE ISSUE WITH THE PAS WAS IN ROOM 3149. AMPLION SUPPORT RESTARTED ROOM 3149 (I.E., RESTARTED THE SERVICE THAT CONTROLS THE SOFTWARE CONNECTED TO THE ROOM'S DEVICES) AND ALL DEVICES REGISTERED IN THE SYSTEM SUCCESSFULLY. AMPLION SUPPORT REQUESTED THAT THE SITE REPRESENTATIVE PRESS THE CODE BLUE BUTTON ON THE PAS IN ROOM 3149. THE CODE BLUE ACTIVATED AND CLEARED SUCCESSFULLY. FAILURE ANALYSIS AMPLION SUPPORT REQUESTED THAT THE PAS REMOVED FROM ROOM 3149 BE RETURNED TO AMPLION. THE DEVICE HAS NOT BEEN RETURNED TO AMPLION AT THE TIME OF THIS REPORT.
Remedial action
- Replace