PUSH TO SET INTERMITTENT SUCTION REGULATOR

Description of Event or Problem

A USER FACILITY REPORTED TO US THAT THE DEVICE "WONT CYCLE OFF" ON (B)(6)2015. THERE WAS NO PATIENT INVOLVEMENT, AND THE INCIDENT DID NOT RESULT IN A DELAY OF TREATMENT. THE DEVICE WAS EVALUATED ON (B)(6) 2015 AND IT WAS NOTED THAT THE DEVICE HAD A DAMAGED DIAPHRAGM. OUR RISK DOCUMENT CLASSIFIES THE SEVERITY OF A DAMAGED DIAPHRAGM AS "POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE". WE ARE OBTAINING FURTHER CLINICAL EVALUATION OF THE RISK OF THIS FAILURE AND WILL PROVIDE FOLLOW UP TO THIS REPORT ONCE OBTAINED.

Additional Manufacturer Narrative

THIS IS A CORRECTION TO REPORT SUBMITTED ON 01/29/2016: A USER FACILITY REPORTED TO US THAT THE DEVICE "GOES FROM FULL TO LOW, HARD TO ADJUST" ON (B)(6) 2015. THERE WAS NO PATIENT INVOLVEMENT, AND THE INCIDENT DID NOT RESULT IN DELAY OF TREATMENT. THE DEVICE WAS EVALUATED ON 04/23/2015 AND IT WAS NOTED THAT THE DEVICE HAD A DAMAGED DIAPHRAGM. OUR RISK DOCUMENT CLASSIFIES THE SEVERITY OF A DAMAGED DIAPHRAGM AS "POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE". WE ARE OBTAINING FURTHER CLINICAL EVALUATION OF THE RISK OF THIS FAILURE AND WILL PROVIDE FOLLOW UP TO THIS REPORT ONCE OBTAINED.

Description of Event or Problem

THIS IS A CORRECTION TO REPORT SUBMITTED ON 01/29/2016: A USER FACILITY REPORTED TO US THAT THE DEVICE "GOES FROM FULL TO LOW, HARD TO ADJUST" ON (B)(6) 2015. THERE WAS NO PATIENT INVOLVEMENT, AND THE INCIDENT DID NOT RESULT IN DELAY OF TREATMENT. THE DEVICE WAS EVALUATED ON 04/23/2015 AND IT WAS NOTED THAT THE DEVICE HAD A DAMAGED DIAPHRAGM. OUR RISK DOCUMENT CLASSIFIES THE SEVERITY OF A DAMAGED DIAPHRAGM AS "POTENTIALLY REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE". WE ARE OBTAINING FURTHER CLINICAL EVALUATION OF THE RISK OF THIS FAILURE AND WILL PROVIDE FOLLOW UP TO THIS REPORT ONCE OBTAINED.

Additional Manufacturer Narrative

CLINICAL ASSESSMENT OF THE FAILURE MODE "DIFFICULT TO ADJUST" HAS BEEN OBTAINED AND IT HAS BEEN DETERMINED THAT THIS OCCURRENCE DOES NOT REPRESENT A REPORTABLE MALFUNCTION DUE TO NO EVIDENCE EXISTING TO REASONABLY SUGGEST THAT THE MALFUNCTION WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. (B)(4).

Description of Event or Problem

CLINICAL ASSESSMENT OF THE FAILURE MODE "DIFFICULT TO ADJUST" HAS BEEN OBTAINED AND IT HAS BEEN DETERMINED THAT THIS OCCURRENCE DOES NOT REPRESENT A REPORTABLE MALFUNCTION DUE TO NO EVIDENCE EXISTING TO REASONABLY SUGGEST THAT THE MALFUNCTION WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF IT WERE TO RECUR.