SMARTMONITOR2 WITH PCMCIA CARD SLOT AND INTERNAL MODEM

Description of Event or Problem

PHILIPS HEALTHCARE RECEIVED A CALL FROM LIFEHME INC ON (B)(6) 2014 STATING THAT THEY WOULD LIKE TO HAVE THEIR DEVICE TESTED/CALIBRATED AFTER A PATIENT HAD PASSED AWAY WHILE ON THE DEVICE. THE CUSTOMER STATED THAT THE DEVICE DID ALARM AS EXPECTED DURING THE EVENT AND THAT THERE IS NO ALLEGATION OF THE DEVICE MALFUNCTIONING.

Additional Manufacturer Narrative

(B)(4): THE SMARTMONITOR 2 DEVICE IS DESIGNED TO MONITOR RESPIRATION, AND HEART RATE. UPON DETECTION OF ABNORMAL EVENTS, SMARTMONITOR 2 ALERTS THE CAREGIVER VIA BOTH VISUAL AND AUDIBLE ALARMS AND RECORDS THE INFORMATION FOR SUBSEQUENT CLINICAL REVIEW. DUE TO A DEATH BEING REPORTED, PHILIPS HEALTHCARE HAS DETERMINED THAT THE REPORTED ISSUE REQUIRED FURTHER INVESTIGATION. PHILIPS HEALTHCARE RECEIVED THE DEVICE FOR EVALUATION. THE UNIT WAS FOUND TO OPERATE AND ALARM APPROPRIATELY FOR SIMULATED EVENTS. NO OBSERVATIONS SUBSTANTIATING A MALFUNCTION OR OTHER OPERATION OUTSIDE OF DESIGN SPECIFICATIONS WERE MADE DURING THE EVALUATION. IT IS CONCLUDED THAT USE OF THE DEVICE DOES NOT PRESENT AN INCREASED RISK TO THE END USER OR PATIENT AND THAT NO CORRECTIVE ACTION OR ADDITIONAL INVESTIGATION IS NECESSARY AT THIS TIME.