BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RED LNC-1 PATIENT CABLE

    MDR report key: 4257635 · Received November 5, 2014

    Report

    Report Number
    2031172-2014-00365
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    September 18, 2014
    Report Date
    October 6, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K053477
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS FOR PRODUCT RETURN AND REQUESTS FOR ADDITIONAL INFORMATION WERE MADE. THE UNIT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF NEW INFORMATION IS OBTAINED OR THE DEVICE IS RETURNED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT "WHEN ATTEMPTING TO USE THE POX (RAD-57) IN THE DELIVERY ROOM FOR RESUSCITATION OF THE BABY, THE PULSE OX. FAILED TO FUNCTION EFFECTIVELY AND WAS UNABLE TO DISPLAY VALUES; PROPER PLACEMENT AND LOCATION CONFIRMED, BUT DID NOT RESOLVE THE ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710453 RED LNC-1 PATIENT CABLE OXIMETER DQA MASIMO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention