THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEY WERE DISAPPOINTED IN THE CLINICAL RESULTS AFTER USING THEIR TRUECPR COACHING DEVICE. THE CUSTOMER ADVISED THAT THEY FELT THAT THE DEVICE WAS NOT PROVIDING ADEQUATE READINGS WHILE THE END USER(S) WERE PROVIDING CPR. AFTER A REVIEW OF THE DEVICE DATA DOWNLOAD, IT WAS OBSERVED THAT ALTHOUGH PROPER COMPRESSION DEPTH WAS BEING ACHIEVED, THE DEVICE WAS INDICATING THAT THE DEPTH WAS TOO SHALLOW WHICH WOULD PROMPT THE USER TO PUSH HARDER TO ACHIEVE A DEEPER COMPRESSION DEPTH. THERE WAS PATIENT USE ASSOCIATED HOWEVER, DETAILS AND THE OUTCOME OF THE PATIENT WAS NOT REPORTED.
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Patient 1
(B)(4). PHYSIO-CONTROL HAS INVESTIGATED AND VERIFIED THE REPORTED ISSUE. PHYSIO HAS DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE IS DUE TO INACCURATE DEPTH MEASUREMENT DISPLAYED BY THE DEVICE AS A RESULT OF A COMBINATION OF FACTORS RELATING TO USER HAND PLACEMENT AND PATIENT ANATOMY. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED ISSUE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.
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Patient 1
CORRECTION INFORMATION: THE INITIAL MEDWATCH REPORT INDICATES: (B)(6) 2013. THE INITIAL MEDWATCH REPORT SHOULD INDICATE: (B)(6) 2013. FOLLOW-UP INFORMATION: PHYSIO-CONTROL EVALUATED THE DEVICE BUT COULD NOT DUPLICATE THE REPORTED FAILURE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. PHYSIO-CONTROL HAS PERFORMED ADDITIONAL CLINICAL AND ENGINEERING ANALYSIS OF THE REPORTED COMPRESSION DEPTH FEEDBACK ACCURACY ISSUE, AND THROUGH THE COURSE OF THAT INVESTIGATION HAS DETERMINED THAT THE DEVICE IS OPERATING WITHIN ITS PRODUCT REQUIREMENTS AND SPECIFICATIONS. IT WAS ALSO DETERMINED THAT THE CURRENT PRODUCT DESIGN MEETS ESTABLISHED USER NEEDS AND ACHIEVES A COACHING BENEFIT TO THE USER FOR DELIVERY OF CARDIOPULMONARY RESUSCITATION (CPR) THERAPY. PHYSIO-CONTROL HAS INVESTIGATED THE REPORTED ISSUE OF INACCURATE DEPTH MEASUREMENT AND HAS VERIFIED THE ISSUE. PHYSIO HAS DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE IS THE RESULT OF A COMBINATION OF FACTORS RELATING TO USER HAND PLACEMENT AND PATIENT ANATOMY.