BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LNOP NEO PT-L

    MDR report key: 5020099 · Received August 20, 2015

    Report

    Report Number
    2031172-2015-01040
    Event Type
    Injury
    Date Received
    August 20, 2015
    Date of Event
    July 14, 2015
    Report Date
    July 22, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS FOR THE RETURN OF THE SENSOR HAVE BEEN MADE IN ORDER TO IDENTIFY THE SENSOR INVOLVED IN THE REPORTED EVENT. THE CUSTOMER INDICATED THAT THE SENSOR USED FOR THIS EVENT WAS DISCARDED AND THE SENSOR LOT INFORMATION WAS NOT AVAILABLE. IF NEW INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE SENSORS PRINTED CIRCUITS PARTS HAD BECOME EXPOSED AND MADE AN ABRADED WOUND ON THE ON THE LEFT FOOT OF THE INFANT. ADDITIONAL INFORMATION RECEIVED INDICATED THERE WAS A SKIN REDNESS THAT ALSO OCCURRED AND NO INFORMATION WAS OBTAINED IF THE AFFECTED AREA WAS HEALED. IT WAS ALSO MENTIONED THAT THE SENSOR WAS CHECK/ROTATED APPROXIMATELY EVERY ONE (1) TO TWO (2) HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552106 LNOP NEO PT-L OXIMETER DQA MASIMO CORPORATION 1651

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Other