SMART MONITOR 2PSL

Additional Manufacturer Narrative

CIRCADIANCE WAS NOT ABLE TO REPLICATE THE CUSTOMER'S COMPLAINT. THE NURSE CALL OUTPUT WAS FOUND TO BE WORKING PROPERLY. A FOLLOW UP PHONE CALL WITH THE CUSTOMER WAS MADE TO DISCUSS THE ISSUE TO DETERMINE IF ANY OTHER ASPECTS OF THE INSTALLATION MIGHT HAVE IMPACTED THE ALARM SIGNAL TRANSMISSION. THE CUSTOMER DESCRIBED A CONNECTION BETWEEN THEIR NURSE CALL SYSTEM AND THE MONITOR THAT SEEMED TO BE APPROPRIATE. DURING THE CONVERSATION, THE CUSTOMER WAS ASKED TO TEST THE MONITOR WHEN IT IS RECEIVED BACK FROM CIRCADIANCE TO VERIFY THAT THEY AGREE THAT THE MONITOR IS WORKING AS INTENDED. THE CUSTOMER WAS ALSO ASKED TO TEST MULTIPLE INTERFACE CABLES AT THEIR SITE TO SEE IF AN INTERFACE CABLE MAY BE MALFUNCTIONING. CIRCADIANCE HAS CHOSEN TO REPORT THIS INCIDENT SINCE THE ACTUAL CAUSE OF THE FAILURE TO TRANSMIT THE ALARM HAS NOT BEEN DETERMINED. IF THE CUSTOMER PROVIDES FOLLOW UP INFORMATION REGARDING TESTING WITH INTERFACE CABLES IN THEIR FACILITY, A FOLLOW UP REPORT WILL BE FILED.

Description of Event or Problem

SAINT FRANCIS HEALTH SYSTEM REPORTED THAT A SMART MONITOR 2PS, MODEL NUMBER 1028970, SERIAL NUMBER (B)(4) HAD AN AUXILLIARY ALARM INTERFACE THAT WAS NOT WORKING. THE BIOMED REPORTED THAT STAFF INFORMED BIOMED THAT THE ALARM WOULD NOT CALL THE DESK THROUGH THE NURSE CALL SYSTEM. THE BIOMED REPORTED THAT SHE VISITED THE LOCATION WHERE THE MONITOR WAS USED AND VERIFIED THAT ALARMS WERE NOT BEING TRANSMITTED TO THROUGH THE NURSE CALL SYSTEM. THE BIOMED ALSO REPORTED THAT THE PRIMARY ALARM IN THE MONITOR WAS WORKING.