Description of Event or Problem · 1
SEE ATTACHED COMPLETE REPORT. QUALITY ISSUES EXIST WITH THIS PRODUCT AND OTHER PRODUCTS INCLUDED WITH THIS REPORT. SAMPLES TESTED: 2. GAUGE ENDURANCE: BOTH UNITS FAILED THE REQUIREMENTS UNDER ANSI. VALVE LEAKAGE: ONE OF THE VALVES EXHIBITED LEAKAGE OF 10 MMHG/MIN, WELL IN EXCESS OF THE 1 MMHG/10 SEC LIMIT MANDATED UNDER ANSI. OPERATING INSTRUCTIONS: NOT INCLUDED AS REQUIRED UNDER ANSI. CALIBRATION INFO INSERT: INCORRECTLY STATES "IF THE NEEDLE RESTS WITHIN THE ZERO INDICATOR ON THE FACEPLATE THE UNIT IS GUARANTEED TO BE ACCURATE". THIS IS SIMPLY NOT TRUE AND COULD BE DANGEROUSLY MISLEADING. ANY GAUGE COULD BE TAMPERED WITH AND HAVE THE NEEDLE REPOSITIONED TO APPEAR ACCURATE. THE STATEMENT SHOULD READ "IF THE NEEDLE RESTS OUTSIDE THE OVAL, THE GAUGE IS IN NEED OF RECALIBRATION". CUFF MARKINGS: THE ARTERY MARK IS NOT POSITIONED OVER THE BLADDER MIDPOINT AS REQUIRED UNDER ANSP. (EXHIBIT A). TRACEABILITY: THIS PRODUCT DOES NOT APPEAR TO HAVE A LOT CODE OR OTHER IDENTIFIER AS PER THE REQUIREMENTS OF ANSI. SAMPLES TESTED: 2. GAUGE ACCURACY: BOTH UNITS FAILED ACCURACY AS PER THE REQUIREMENTS OF ANSI, THOUGH ONE FAILED ONLY AT A SINGLE TEST POINT. GAUGE ENDURANCE: THE ONE UNIT TESTED FAILED THE REQUIREMENTS UNDER ANSI. OPERATING INSTRUCTIONS: NOT INCLUDED AS REQUIRED UNDER ANSI. CALIBRATION INFO INSERT: INCORRECTLY STATES "IF THE NEEDLE RESTS WITHIN THE ZERO INDICATOR ON THE FACEPLATE THE UNIT IS GUARANTEED TO BE ACCURATE". THIS IS SIMPLY NOT TRUE AND COULD BE DANGEROUSLY MISLEADING. ANY GAUGE COULD BE TAMPERED WITH AND HAVE THE NEEDLE REPOSITIONED TO APPEAR ACCURATE. THE STATEMENT SHOULD READ "IF THE NEEDLE RESTS OUTSIDE THE OVAL, THE GAUGE IS IN NEED OF RECALIBRATION". (EXHIBIT B). CUFF MARKINGS: THE ARTERY MARK IS NOT POSITIONED OVER THE BLADDER MIDPOINT AS REQUIRED UNDER ANSP. CUFF LABELING: THE CUFFS DO NOT HAVE THE PROPER LIMB RANGE MARKINGS ON THEM AS REQUIRED BY ANSI. QUALITY ISSUES EXIST WITH THIS PRODUCT AND OTHER PRODUCTS INCLUDED WITH THIS REPORT. SAMPLES TESTED: 2. THERMOMETER ACCURACY: BOTH SAMPLES FAILED TO MEET THE ACCURACY REQUIREMENT UNDER ASTM, THOUGH SAMPLE 1 WAS WITHIN THE ACCURACY LIMITS OF OUR TEST MACHINE. SAMPLE TWO REGISTERED ONE TEST POINT THAT WAS OFF BY ALMOST THREE TIMES THE ALLOWED LIMIT. SAMPLES TESTED: 2. THERMOMETER ACCURACY: BOTH SAMPLES FAILED TO MEET THE ACCURACY REQUIREMENT UNDER ASTM. AT ONE TEST POINT, BOTH SAMPLES WERE OFF BY THREE TIMES THE ALLOWED LIMIT. SAMPLES TESTED: 2. THERMOMETER ACCURACY. BOTH SAMPLES FAILED TO MEET THE ACCURACY REQUIREMENTS UNDER ASTM. AT ONE TEST POINT, BOTH SAMPLES WERE OFF BY UP TO THREE TIMES THE ALLOWED LIMIT. LOT NUMBER: THEY APPEAR TO USE A DATE BASED LOT NUMBERING SYSTEM (LOCATED ON THE RATING LABEL). WITH A LOT DATES OF 02/06 ON ONE SAMPLE IT WOULD SUGGEST THEY ARE NOT WITHIN THE 2 YEAR LIFE RATING OF THE BATTERIES. (EXHIBIT D). DOSE OR AMOUNT, FREQUENCY, ROUTE: #- NA. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: BLOOD PRESSURE MEASUREMENT - TEMPERATURE MEASUREMENT.