DOPPLEX DIGITAL HANDHELD

Additional Manufacturer Narrative

THE DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. THE INVESTIGATION DETERMINED THAT THE DEVICE EXPERIENCED A MALFUNCTION TRACED TO A COMPONENT FAILURE. REVIEW OF POST MARKET SURVEILLANCE DATA INDICATES THAT THIS REPRESENTS AN ISOLATED OCCURRENCE, WITH NO IDENTIFIED TRENDS OR EVIDENCE OF A BROADER SYSTEMIC ISSUE REQUIRING FURTHER CORRECTIVE OR PREVENTIVE ACTION AT THIS TIME. THE CLINICAL OUTCOME APPEARS TO HAVE BEEN INFLUENCED BY RELIANCE ON A SINGLE DEVICE MEASUREMENT IN ISOLATION WHEN MAKING A TREATMENT DECISION. IN ADDITION, PRE-USE FUNCTIONAL CHECKS OF THE PROBE WERE NOT ADEQUATELY PERFORMED. ALTHOUGH AN INITIAL CHECK INDICATED A ¿FAINT NOISE,¿ THERE WAS NO CONFIRMATION THAT THE PROBE WAS PRODUCING AN ACCEPTABLE SIGNAL OUTPUT FOR CLINICAL USE, THIS SHOULD HAVE RESULTED IN THE PROBE BEING IDENTIFIED AS FAULTY PRIOR TO USE. THE INSTRUCTIONS FOR USE (IFU) CLEARLY STATES THAT DOPPLER DEVICES ARE INTENDED AS SCREENING TOOLS TO SUPPORT CLINICAL ASSESSMENT AND THAT, IN CASES OF UNCERTAINTY REGARDING VASCULAR STATUS, FURTHER INVESTIGATIONS USING ALTERNATIVE DIAGNOSTIC TECHNIQUES SHOULD BE UNDERTAKEN. FURTHERMORE, ESTABLISHED CLINICAL GUIDANCE, INCLUDING THE GLOBAL VASCULAR GUIDELINES FOR CHRONIC LIMB THREATENING ISCHAEMIA (CLTI), EMPHASISES THE IMPORTANCE OF COMPREHENSIVE ASSESSMENT. THIS INCLUDES OBJECTIVE HAEMODYNAMIC TESTING, SUCH AS TOE PRESSURE MEASUREMENTS, AND THE USE OF VALIDATED CLASSIFICATION SYSTEMS (E.G. WIFI) TO SUPPORT ACCURATE STAGING AND CLINICAL DECISION MAKING. BASED ON THE AVAILABLE EVIDENCE, THE ADVERSE EVENT IS ATTRIBUTED TO THE USE OF A SINGLE DIAGNOSTIC MEASUREMENT WITHOUT APPROPRIATE ADDITIONAL ASSESSMENTS, COMBINED WITH INADEQUATE VERIFICATION OF DEVICE FUNCTIONALITY PRIOR TO USE. H3 OTHER TEXT : DEVICE HAS ALREADY BEEN REPAIRED BY THE USER

Description of Event or Problem

AN UNNECESSARY INTERVENTION WAS PERFORMED ON A PATIENT FOLLOWING AN INCORRECT SIGNAL FROM A HUNTLEIGH HANDHELD DOPPLER. THE DOPPLER WAS TESTED BEFORE USE. IT DID PRODUCE A "FAINT NOISE" THEN. WHEN IT WAS USED ON THE PATIENT, NO PULSE WAS DETECTED. THE DOCTOR THOUGHT THERE WAS NO BLOOD FLOW IN THE EXTREMITY OF THE PATIENT. THE PATIENT SAID THAT THE EXTREMITY FELT NUMB. BECAUSE THE DOCTOR THOUGHT THE BLOODFLOW WAS OBSTRUCTED, THE PATIENT WAS BROUGHT TO THE OPERATING ROOM AND WAS "OPENED". THEN THEY FOUND OUT, THE BLOOD FLOW WAS FINE. THE INTERVENTION WAS THEREFORE UNNECESSARY.