OXIMAX OXI-A/N OXIBAND SENSOR

Additional Manufacturer Narrative

(B)(4). THIS IS THE THIRD REPORTING OF FOUR REPORTS. REFERENCING 2936999-2013-00373, 2936999-2013-00374, 2936999-2013-00375, AND 2936999-2013-00376. PER INFO PROVIDED IN THE OXIMAX OXI-A/N OXIBAND DIRECTIONS FOR USE IN REGARDS TO POSSIBLE CAUSES FOR INACCURATE READINGS: INDICATIONS/CONTRAINDICATIONS: THE NELLCOR OXIBAND ADULT/NEONATAL OXYGEN SENSOR, MODEL OXI-A/N IS INDICATED FOR USE WHEN CONTINUOUS NONINVASIVE ARTERIAL OXYGEN SATURATION AND PULSE RATE MONITORING ARE REQUIRED FOR PTS WEIGHING LESS THAN 3 KG OR MORE THAN 40 KG. INSTRUCTIONS FOR USE: REUSABLE SENSORS MAY BE USED ON THE SAME SITE FOR A MAXIMUM OF 4 HOURS, PROVIDED THE SITE IS INSPECTED ROUTINELY TO ENSURE SKIN INTEGRITY, CORRECT POSITIONING, AND ADHESION OF THE SENSOR WRAP. NOTE: IF THE SENSOR DOES NOT TRACK THE PULSE RELIABLY, IT MAY BE INCORRECTLY POSITIONED - OR THE SENSOR SITE MAY BE TOO THICK, THIN OR DEEPLY PIGMENTED, OR OTHERWISE DEEPLY COLORED (FOR EXAMPLE, AS A RESULT OF EXTERNALLY APPLIED COLORING SUCH AS NAIL POLISH, DYE OR PIGMENTED CREAM) TO PERMIT APPROPRIATE LIGHT TRANSMISSION. IF ANY OF THESE SITUATIONS OCCURS, REPOSITION THE SENSOR OR CHOOSE AN ALTERNATE NELLCOR SENSOR FOR USE ON A DIFFERENT SITE. WARNINGS: USING THE OXI-A/N IN THE PRESENCE OF BRIGHT LIGHTS MAY RESULT IN INACCURATE MEASUREMENTS. IN SUCH CASES, COVER THE SENSOR SITE WITH AN OPAQUE MATERIAL. INTERVASCULAR DYES OR EXTERNALLY APPLIED COLORING SUCH AS NAIL POLISH, DYE OR PIGMENTED CREAM MAY LEAD TO INACCURATE MEASUREMENTS. EXCESSIVE MOTION MAY COMPROMISE PERFORMANCE. IN SUCH CASES, TRY TO KEEP THE PT STILL, OR CHANGE THE SENSOR SITE TO ONE WITH LESS MOTION. WHEN THE SENSOR IS WRAPPED TOO TIGHTLY OR SUPPLEMENTAL TAPE IS APPLIED, VENOUS PULSATIONS MAY LEAD TO INACCURATE SATURATION MEASUREMENTS.

Description of Event or Problem

SENSORS MEASURE TOO LOW VALUES. AT A COMPARISON MEASUREMENT BETWEEN MAX-N-I AND OXI-A/N SENSORS THE OXI-A/N ALWAYS SHOWED 2-5% LESS SATURATION. NO PT HARM.