| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SMARTMONITOR 2 WITH MODEM | APNEA MONITOR | CIRCADIANCE LLC | FLS | 4003 | 4003 | N | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-09-30 | 0 | 1. D |
Patient 1
MULTIPLE ATTEMPTS HAVE BEEN MADE TO COORDINATE FOR THE DOWNLOAD OF DEVICE INFO THROUGH PHILIPS HEALTHCARE LEGAL DEPT. AS OF THE TIME OF THIS REPORT SUBMISSION, THEY HAVE NOT REPLIED TO OUR REQUESTS. WE WILL CONTINUE TO ATTEMPT TO COORDINATE TO HAVE THE DEVICE MADE AVAILABLE TO US FOR EVALUATION AND UPON COMPLETION OF OUR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED.
Patient 1
CIRCADIANCE LLC RECEIVED A COMPLAINT FROM PHILIPS HEALTHCARE THAT INVOLVED PHILIPS HEALTHCARE BEING NOTIFIED BY THE LAW FIRM (B)(6) THAT THEY REPRESENTS A CLIENT WHOSE CHILD WAS PRESCRIBED AND HOOKED UP TO A SMARTMONITOR 2 PROVIDED BY (B)(4) AND MANUFACTURED BY RESPIRONICS INC. THE CLIENTS CLAIMS THAT THE MONITOR DID NOT SOUND WHEN IT SHOULD HAVE SOUNDED, RESULTING IN 911 BEING CALLED AND THE CHILD BEING HOSPITALIZED UNTIL HIS DEATH ON (B)(6) 2015. THE DATE THAT THE MONITOR IS ALLEGED TO HAVE NOT SOUNDED WAS NOT INCLUDED IN THE NOTIFICATION. THE LAW FIRM HAS THE MONITOR AND WILL PRESERVE IT UNTIL THEY CAN HAVE IT DOWNLOADED. THEY ARE IN THE PROCESS OF OBTAINING MEDICAL RECORDS AND THE EMT REPORT FOR THE INCIDENT AND WILL SHARE THIS INFO.
Patient 1
CIRCADIANCE, LLC HAS COMPLETED ITS INVESTIGATION OF THE ALLEGED SMARTMONITOR 2 PRODUCT FAILURE ASSOCIATED WITH A PATIENT DEATH. THE INVESTIGATION CONCLUDED THAT THE COMPLAINT ISSUE ALLEGED BY THE CUSTOMER WAS NOT ABLE TO BE CONFIRMED. THE DEVICE WAS ANALYZED BY A CLINICAL PRODUCT SPECIALIST WITH PHILIPS HEALTHCARE IN THE PRESENCE OF LEGAL REPRESENTATION. THE DEVICE'S DATA DOWNLOAD WAS ANALYZED AND FOUND TO SHOW THAT THE DEVICE WAS NOT PUT INTO USE ON THE DAY OF THE REPORTED EVENT. FURTHER ANALYSIS OF THE DATA DOWNLOAD SHOWED THAT THE DEVICE WAS OPERATING TO SPECIFICATION AND APPROPRIATELY DETECTED AND ALARMED FOR PATIENT EVENTS WHILE IN OPERATION. THE EVALUATION OF THE DEVICE DID NOT INCLUDE FUNCTIONAL TESTING AS THE DEVICE WAS NOT PHYSICALLY RETURNED TO CIRCADIANCE, LLC. 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. BASED ON A COMPLETE REVIEW OF THE COMPLAINT, CIRCADIANCE HAS DETERMINED THAT THERE IS NO REASON TO BELIEVE THE DEVICE IN QUESTION WOULD NOT PERFORM TO SPECIFICATION. NO OBSERVATIONS SUBSTANTIATING A MALFUNCTION OR OTHER OPERATION OUTSIDE OF DESIGN SPECIFICATIONS WERE MADE DURING THE EVALUATION OF THE DEVICE. IT IS CONCLUDED THAT USE OF THE DEVICE DOES NOT PRESENT A NEW OR INCREASED RISK TO THE PATIENT OR USER AND THAT NO CORRECTIVE ACTION OR ADDITIONAL INVESTIGATION ACTIVITY IS NECESSARY AT THIS TIME.