BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LNOP NEO-L ADHESIVE

    MDR report key: 3830136 · Received May 9, 2014

    Report

    Report Number
    2031172-2014-00046
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K120657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS WERE MADE TO OBTAIN THE PRODUCT AND ADDITIONAL INFORMATION FROM THE CUSTOMER. MASIMO WAS INFORMED THE SENSOR USED FOR THIS EVENT WAS DISCARDED. THE SENSOR LOT INFORMATION WAS NOT AVAILABLE. RETAINS OF THE SAME REPORTED SENSOR TYPE, LNOP NEO-L ADHESIVE, WERE TESTED AND FOUND TO BE FUNCTIONING AS DESIGNED. THE CUSTOMER CONFIRMED THE NURSING STAFF WAS REAPPLYING THE SENSOR AFTER CHECKING THE APPLICATION SITE PER HOSPITAL PROTOCOL, HOWEVER, THEY WERE NOT REPLACING THE ADHESIVE WRAP AS NEEDED. SUPPLEMENTAL EDUCATION WAS PROVIDED TO ALL HOSPITAL STAFF REGARDING REPLACEMENT OF THE ADHESIVE WRAP.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE CUSTOMER: THE SENSOR DOESN'T STICK VERY WELL AND THE READING, WHEN APPLIED, ARE 30-45 PERCENT. THE SENSOR IS BEING USED WITH A PANDA GE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281131 LNOP NEO-L ADHESIVE DQA MASIMO CORPORATION LNOP NEO-L

    Patients

    Seq Age Sex Outcome Treatment
    1 PANDA GE| VENTILATOR