D
Patient 1
FOUND THAT THIS INSTRUMENT BOARD MEASURES SATURATION OF HEMOGLOBIN WITH OXYGEN AS MEASURED BY PULSE OXIMETRY (SPO2) INACCURATELY. IN VARIOUS TESTING IT WAS ISOLATED TO THIS DEVICE, OTHER COMPATIBLE BATTERY AND ROOT DEVICES WILL NOT CHANGE THE EFFECT OF THE ERROR. THE DEVICE MEASURES SPO2 INACCURATELY. ACCURACY RANGES FROM A MINIMUM 4% DIFFERENCE (4.1% ERROR) TO 63 % DIFFERENCE (65% ERROR). THE TESTING WAS CONDUCTED ON TWO DIFFERENT FLUKE PROSIM 8'S WITHIN CALIBRATION SPEC, AND SPOT SPO2 TESTERS. SIMULATION DEVICES WERE SET FOR MASIMO SETTINGS AT 97% PERFUSION. MEASUREMENTS RANGED FROM 34%-93%. MANUFACTURER RESPONSE FOR MASIMO RADIUS 7 INSTRUMENT BOARD, MASIMO (PER SITE REPORTER). REQUESTED THE DEVICE FOR EVALUATION. NO FURTHER RESPONSE AT THIS TIME.