BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LNOP NEO-L

    MDR report key: 4997578 · Received August 12, 2015

    Report

    Report Number
    2031172-2015-00990
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    July 10, 2015
    Report Date
    July 12, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K040214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS WERE MADE TO OBTAIN THE PRODUCT AND ADDITIONAL INFORMATION FROM THE CUSTOMER. MASIMO WAS INFORMED THAT THE SENSOR USED FOR THIS EVENT WAS DISCARDED. RETAINS OF THE SAME REPORTED SENSOR LOT WERE TESTED AND FOUND TO BE FUNCTIONING AS DESIGNED. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER FOUR (4) MONTHS WITH NO PREVIOUS REPORTED ISSUES PRIOR TO THIS REPORTED EVENT. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND IT WAS DETERMINED THAT THE DEVICE MET ALL RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED TO DATE TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED. THE CUSTOMER INDICATED THAT THE AREA HAD HEALED/RESOLVED ON ITS OWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SKIN REDNESS APPEARED AFTER THE THIRD DAY OF USE EVEN THOUGH SPONGE TAPE OVER THE LED WAS APPLIED. ADDITIONAL INFORMATION RECEIVED MENTIONED THAT A SKIN REDNESS WAS ON THE PLANTAR PART WITH BOTH FEET. THE CUSTOMER ALSO STATED THE SENSOR SITE WAS ROTATED EVERY THREE HOURS AND USUALLY RELIEVED SOON AFTER CHANGE THE SENSOR APPLY SITE, BUT, THIS TIME IT REMAINED. A TOPICAL OINTMENT WAS APPLIED AND HAS SINCE HEALED. THE CUSTOMER ALSO STATED THE SENSOR WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527907 LNOP NEO-L OXIMETER DQA MASIMO CORPORATION 1798-1 15CEM

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Other