SMART MONITOR 2PS

Additional Manufacturer Narrative

THE NURSE CALL JACK IN THIS MONITOR WAS PHYSICALLY DAMAGED RENDERING THE OUTPUT INOPERABLE. CIRCADIANCE HAS RECENTLY RE-EVALUATED REPORTING DECISIONS RELATED TO PHYSICALLY DAMAGED NURSE CALL JACKS. CIRCADIANCE HAS MADE THE DECISION TO REPORT THESE INSTANCES OF DAMAGED NURSE CALL JACKS WHERE THE JACK IS STILL PHYSICALLY INTACT AND IT IS POSSIBLE THAT THE USER MAY HAVE PERCEIVED THAT THEY WERE STILL ABLE TO MAKE A CONNECTION TO THE JACK. THIS COMPLAINT WAS RECEIVED PRIOR TO THE RE-EVALUATION OF REPORTING, HOWEVER, THE EVENT OCCURRED RELATIVELY RECENTLY. THUS CIRCADIANCE HAS RE-CLASSIFIED THIS COMPLAINT AND HAS RETROSPECTIVELY FILED THIS REPORT TO BE CONSISTENT WITH THE RECENT INTERNAL CHANGES REGARDING REPORTING THESE EVENTS. THE PRIMARY ALARM IN THIS MONITOR AS WELL AS ALL OF THE MONITORING PARAMETERS WERE CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION.

Description of Event or Problem

(B)(6) HOSPITAL SENT A SMART MONITOR 2PS MODEL NUMBER 1030271, SERIAL NUMBER (B)(4) IN FOR SERVICE REQUESTING THAT CIRCADIANCE CHECK THE OVERALL PERFORMANCE OF THE MONITOR. THE CUSTOMER DID NOT ALLEGE THAT THE PRODUCT WAS MALFUNCTIONING. THEY JUST REQUESTED THAT THE DEVICE BE EVALUATED. DURING SERVICE EVALUATION, THE SERVICE TECHNICIAN DETERMINED THAT THE NURSE CALL JACK WAS PARTIALLY DISLODGED FROM THE MAIN CIRCUIT BOARD RENDERING THE NURSE CALL OUTPUT NONFUNCTIONAL.