BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX OXI-A/N OXIBAND SENSOR

    MDR report key: 3130189 · Received May 21, 2013

    Report

    Report Number
    2936999-2013-00375
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 22, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCO H
    Product Code
    DPZ
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (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 · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225501 OXIMAX OXI-A/N OXIBAND SENSOR ADULT/NEONATAL OXYGEN SENSOR DPZ COVIDIEN, FORMERLY TYCO H 122650027X

    Patients

    Seq Age Sex Outcome Treatment
    1