BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX ADULT OXYGEN SENSOR

    MDR report key: 3250117 · Received July 23, 2013

    Report

    Report Number
    2936999-2013-00547
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 27, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCO
    Product Code
    NLF
    PMA / PMN Number
    K052186
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN REQUESTED INFORMATION ON INCIDENT SUCH AS: PLACEMENT OF THE SENSOR, HOW LONG SENSOR WAS IN USED, HOW OFTEN THE SITE WAS CHECKED/ CHANGED BUT USER FACILITY WAS NOT ABLE TO PROVIDE FURTHER DETAILS. PER OXIMAX MAX-A DIRECTIONS FOR USE: INDICATIONS/ CONTRAINDICATIONS - THE NELLCOR OXIMAX ADULT OXYGEN SENSOR, MODEL MAX-A (L) IS INDICATED FOR SINGLE PATIENT USE WHEN CONTINUOUS NONINVASIVE ARTERIAL OXYGEN SATURATION AND PULSE RATE MONITORING ARE REQUIRED FOR PATIENTS WEIGHING MORE THAN 30 KG. INSTRUCTIONS FOR USE - AN INDEX FINGER IS THE PREFERRED MAX-A (L) LOCATION. ALTERNATIVELY, APPLY THE SENSOR TO A SMALL THUMB, SMALLER FINGER, OR GREAT TOE. NOTE: WHEN SELECTING A SENSOR SITE, PRIORITY SHOULD BE GIVEN TO AN EXTREMITY FREE OF AN ARTERIAL CATHETER, BLOOD PRESSURE CUFF, OR INTRAVASCULAR INFUSION LINE. 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. CAUTIONS - FAILURE TO APPLY THE MAX-A (L) PROPERLY MAY CAUSE INCORRECT MEASUREMENTS. WHILE THE MAX-A (L) IS DESIGNED TO REDUCE THE EFFECTS OF AMBIENT LIGHT, EXCESSIVE LIGHT MAY CAUSE INACCURATE MEASUREMENTS. IN SUCH CASES, COVER THE SENSOR WITH OPAQUE MATERIAL. CIRCULATION DISTAL TO THE SENSOR SITE SHOULD BE CHECKED ROUTINELY. THE SITE MUST BE INSPECTED EVERY 8 HOURS TO ENSURE ADHESION, SKIN INTEGRITY, AND CORRECT OPTICAL ALIGNMENT. IF SKIN INTEGRITY CHANGES, MOVE THE SENSOR TO ANOTHER SITE. INTRAVASCULAR 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 PATIENT STILL, OR CHANGE THE SENSOR SITE TO ONE WITH LESS MOTION. DO NOT IMMERSE IN WATER OR CLEANING SOLUTIONS. DO NOT RESTERILIZE. IMMERSION OR RESTERILIZATION COULD DAMAGE THE SENSOR. IF THE SENSOR IS WRAPPED TOO TIGHTLY OR SUPPLEMENTAL TAPE IS APPLIED, VENOUS PULSATIONS MAY LEAD TO INACCURATE SATURATION MEASUREMENTS. DO NOT ALTER OR MODIFY THE MAX-A (L). ALTERATIONS OR MODIFICATIONS MAY AFFECT PERFORMANCE OR ACCURACY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN SALES REPRESENTATIVE THAT MAXA SENSOR WAS PROVIDING LOW READINGS. IT WAS REPORTED THAT THE READINGS WERE IN THE 80% RANGE; CONSISTENTLY SHOWING SPO2 10% LOWER. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343122 OXIMAX ADULT OXYGEN SENSOR OXIMAX MAXA OXYGEN SENSOR NLF COVIDIEN, FORMERLY TYCO MAXA 130740044X

    Patients

    Seq Age Sex Outcome Treatment
    1 MP90| MP30| PHILIPS M3001A MODULES