| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SMARTMONITOR 2 WITH PCMCIA CARD SLOT AND INTERNAL MODEM | APNEA MONITOR | PHILIPS MEDICAL SYSTEMS | FLS | 4003 | R | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-06-12 | 0 | 1. R |
Patient 1
PHILIPS HEALTHCARE RECEIVED A COMPLAINT FROM A DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER STATING THAT A SMART MONITOR 2 DEVICE FAILED TO ALARM. THE DME STATED THAT THE PATIENT WAS FOUND BLUE AND TRANSPORTED TO THE HOSPITAL WHERE THE PATIENT WAS SUCCESSFULLY RESUSCITATED WITH NO LASTING IMPACT.
Patient 1
THE SMART MONITOR 2 DEVICE IS DESIGNED TO MONITOR RESPIRATION, AND HEART RATE. UPON DETECTION OF ABNORMAL EVENTS, SMART MONITOR 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 ALLEGATION, PHILIPS HEALTHCARE HAS DETERMINED THAT THE REPORTED ISSUE REQUIRES FURTHER INVESTIGATION. ONCE THE DEVICE IS RETURNED FOR INVESTIGATION OR ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP ADDITIONAL INFORMATION REPORT WILL BE FILED TO DETAIL THE FINDINGS AND THE NEED FOR ANY POSSIBLE FURTHER ACTION.
Patient 1
MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ABOUT THE REPORTED INCIDENT AND TO OBTAIN THE PRODUCT BACK FOR EVALUATION. TWO PEOPLE WERE CONTACTED AT THE CUSTOMER SITE. ONE DID NOT HAVE ANY ADDITIONAL INFORMATION ABOUT THE EVENT, BUT DID HAVE A COPY OF THE DEVICE DOWNLOAD, WHICH PROVIDES DATA SHOWING WHEN THE DEVICE WAS IN USE AND WHEN THE DEVICE WAS ALARMING. THIS SAME PERSON ALSO CONTACTED THE PATIENT?S PARENTS FOR MORE INFORMATION RELATED TO THE TIME OF THE ACTUAL EVENT, BUT CLAIMED THAT THE PARENTS DID NOT REMEMBER THIS INFORMATION. THE OTHER PERSON AT THE CUSTOMER SITE STATED THAT THE DEVICE WILL NOT BE RETURNING FOR EVALUATION AND DID NOT HAVE ANY ADDITIONAL INFORMATION ABOUT THE EVENT. THE DEVICE DOWNLOAD OBTAINED SHOWED THAT THE DEVICE WAS IN USE FROM 6:22AM TO 12:52PM AND AGAIN FROM 1:32PM TO 1:56PM ON (B)(6) 2015. THE DEVICE ALARMED FOR A TACHYCARDIA AT 6:23AM AND A BRADYCARDIA AT 12:50PM WHILE IN USE, BUT WITHOUT KNOWING THE TIME OF THE ALLEGED INCIDENT IT CAN?T BE CONFIRMED IF THE DEVICE WAS IN USE OR ALARMING AT THE TIME OF THE ALLEGED FAILURE. BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE TIME OF THE INCIDENT IS UNKNOWN, THE REPORTED PROBLEM CANNOT BE CONFIRMED. THE PRODUCT REMAINS AT THE CUSTOMER SITE. EVALUATION OF THE DEVICE DOWNLOAD SHOWED THAT THE DEVICE WAS IN USE DURING CERTAIN TIME PERIODS ON THE DAY OF THE REPORTED INCIDENT AND THE DEVICE ALARMED MULTIPLE TIMES WHILE IN USE. THE INVESTIGATION COULD NOT DETERMINE WHETHER THE PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT OUTCOME BECAUSE THE CUSTOMER DID NOT RETURN THE DEVICE FOR EVALUATION OR KNOW THE TIME OF THE INCIDENT FOR COMPARISON WITH THE DEVICE DOWNLOAD. THEREFORE, WE ARE CONSIDERING THIS TO BE A MALFUNCTION OF INSUFFICIENT INFORMATION/UNKNOWN CAUSE FOR REPORTING PURPOSES ONLY.
Patient 1
PHILIPS HEALTHCARE RECEIVED A COMPLAINT FROM A (B)(4) SUPPLIER STATING THAT A SMART MONITOR 2 DEVICE FAILED TO ALARM. THE (B)(4) STATED THAT THE PATIENT WAS FOUND BLUE AND TRANSPORTED TO THE HOSPITAL WHERE THE PATIENT WAS SUCCESSFULLY RESUSCITATED WITH NO LASTING IMPACT.