SMART MONITOR 2

Description of Event or Problem

A CUSTOMER ALLEGED AN APNEA MONITOR FAILED TO AUDIBLY ALARM IN A VOLUNTARY MEDWATCH (B)(4) REPORT SUBMITTED TO THE FDA IN (B)(6) 2009. THE FDA FORWARDED THIS REPORT TO US (THE MFR) ON (B)(6) 2009. THE REPORT ALLEGED NO HARM OR INJURY ASSOCIATED WITH THE PERFORMANCE OF THE APNEA MONITOR (B)(4). A REVIEW OF THE VOLUNTARY MEDWATCH REPORT (B)(4) REVEALED THAT (B)(6) SUPPLIER WHO HAD PROVIDED THE APNEA MONITOR TO THE COMPLAINANT HAD PREVIOUSLY BEEN CONTRACTED BY US (THE MFR) REGARDING A SIMILAR COMPLAINT WITH DIFFERENT APNEA MONITOR (REF MED 2518422-2009-00011). THIS CONTACT OCCURRED ON (B)(6) 2009. DURING THAT CONTACT, THE DME INFORMED US THAT THE APNEA MONITOR SN (B)(4) HAD BEEN PLACED INTO USE IN THE COMPLAINANT'S HOME ON (B)(6) 2006, AFTER COMPLETION OF THE CHECK OUT PROCEDURE IDENTIFIED IN PRODUCT LABELING (RESPIRONICS SMART MONITOR 2 CHECKOUT PROCEDURE MANUAL, (B)(4)) AND EDUCATING THE CAREGIVER REGARDING THE OPERATION OF THE MONITOR. THE (B)(6) ADDITIONALLY STATED THAT THE COMPLAINANT HAD REQUESTED REPLACEMENT OF THE SUBJECT APNEA MONITOR ON (B)(6) 2006, BUT DID NOT PROVIDE AN EXPLANATION OF WHY THE COMPLAINANT REQUESTED THE REPLACEMENT. THEY ALSO (WE BELIEVE AS A RESULT OF THEIR TESTING OF THE DEVICE) DID NOT INFORM US OF ANY PRODUCT PROBLEMS AFTER THEY REMOVED THE MONITOR FROM THE COMPLAINANT'S HOME. OUR REVIEW OF THE HISTORY FOR THE SUBJECT DEVICE, THE INFO FOR THIS REPORT, AND OUR COMMUNICATION WITH THE DME HAS REVEALED NO EVIDENCE OF THE DEVICE MALFUNCTIONING OR CAUSING ANY HARM/INJURY. THIS LEADS US TO BELIEVE THE DEVICE OPERATED AS DESIGNED WHEN THE EVENT THAT LED TO THE CUSTOMER'S COMPLAINT ALLEGATION (THAT THE DEVICE DID NOT ALARM AS DESIGNED) OCCURRED. TO FURTHER SUBSTANTIATE OUR CONCLUSION THAT THE SUBJECT DEVICE OPERATED AS DESIGNED DURING THE REPORTED EVENT (AND EXPLAIN WHY NO COMPLAINT WAS MADE AGAINST THE DEVICE AT THE TIME OF EVENT) WE COMPLETED A REVIEW OF OUR COMPLAINT DATABASE FOR COMPLAINTS AGAINST THE MONITOR SN (B)(4). NO COMPLAINTS OR SERVICE RECORDS WERE RECORDED AGAINST THE SUBJECT DEVICE ON OR AROUND (B)(6) 2006, OR AT ANY TIME SINCE THE DEVICE WAS RELEASED INTO DISTRIBUTION IN (B)(6) 2003. BASED ON THIS FINDING, WE CONCLUDE, THAT THE APNEA MONITOR IDENTIFIED IN THIS REPORT OPERATED AS DESIGNED RELATIVE TO THE COMPLAINANT'S ALLEGATION. WE DRAW THIS CONCLUSION BASED ON THE FACT THAT PRODUCT LABELING CLEARLY AND ADEQUATELY DETAILS OPERATIONAL CHECKS, AND CARE AND HANDLING GUIDELINES; AND BECAUSE WE FIND NO EVIDENCE THAT THE MONITOR HAD EVER REQUIRED SERVICING OF ANY TYPE AS A RESULT OF FAILING ANY TESTS AND OR CHECKS, OR PERFORMING IN A MANNER THAT INDICATING SERVICING WAS REQUIRED. THE LABELING WE FIND THAT SUPPORTS OUR CONCLUSION IS INCLUDED IN "THE PROFESSIONAL MANUAL FOR THE SMART MONITOR 2 ((B)(4), REV. B)" WHICH STATES "THIS RESPIRONICS EQUIPMENT AND THE AUTHORIZED ACCESSORIES ARE DESIGNED TO WORK AS DESCRIBED IN THE OPERATOR'S MANUAL. THE USER(S) OF THIS EQUIPMENT SHOULD NOT USE PARTS THAT HAVE FAILED, EXHIBIT EXCESSIVE WEAR, ARE CONTAMINATED, OR OTHERWISE INEFFECTIVE. THE MONITOR AND ITS ACCESSORIES SHOULD NOT BE MODIFIED" AND "THE USER OF THIS EQUIPMENT IS RESPONSIBLE FOR READING, UNDERSTANDING, AND FOLLOWING THE WARNING AND CAUTION STATEMENTS THROUGHOUT THIS MANUAL." ADD'L LABELING STATES THE CAREGIVER HAS THE RESPONSIBILITY OF ENSURING THE PROPER FUNCTION OF THE APNEA MONITOR USING THE DEVICE'S FUNCTIONAL SELF-TEST CHECKS, AND THAT THESE TESTS SHOULD BE PERFORMED AT LEAST ONCE A WEEK OR ACCORDING TO THE INSTRUCTIONS GIVEN BY YOUR HEALTH CARE PROFESSIONAL. PRODUCT LABELING ALSO STATES THAT IF THE DEVICE DOES NOT PERFORM ACCORDING TO PRODUCT LABELING (INCLUDING THE SELF-TEST CHECKS) TO CONTACT THE DEALER (B)(6), AND FINALLY, PRODUCT LABELING STATES "DO NOT USE YOUR MONITOR IF THE ALARM SOUNDS WEAK OR DOES NOT ACTIVATE UPON INITIAL POWER-ON" (REFERENCE "PARENTS' GUIDE FOR THE SMART MONITOR 2" (B)(4). BASED ON ALL AVAILABLE DATA WE BELIEVE THAT THE APNEA MONITOR ASSOCIATED WITH THIS REPORT OPERATED AS DESIGNED RELATIVE TO THE REPORTED ALLEGATION AND THAT NO FURTHER ACTION IS APPROPRIATE.

Additional Manufacturer Narrative

METHOD: (REVIEW OF COMPLAINT AND SERVICE RECORDS PERFORMED). RESULTS: (NO COMPLAINTS OR SERVICE RECORDS WERE IDENTIFIED).