BEUDAMED
    FDA Adverse Event Death Summary report: N

    RAD-8

    MDR report key: 3885750 · Received June 13, 2014

    Report

    Report Number
    2031172-2014-00058
    Event Type
    Death
    Date Received
    June 13, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K053269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TREND DATA WAS DOWNLOADED AND DEVICE FUNCTIONALITY WAS VERIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REQUESTED THAT THE TREND DATA BE EXTRACTED FROM THE DEVICE. THE CUSTOMER WOULD LIKE TREND INFO FROM (B)(6) IF POSSIBLE. THE PT DIED; HOWEVER, THERE WAS NO REPORTED PROBLEM WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351046 RAD-8 DQA MASIMO CORPORATION RAD-8

    Patients

    Seq Age Sex Outcome Treatment
    1 17 MO Death