BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADICAL-7 COLOR SCREEN HANDHELD

    MDR report key: 3896975 · Received June 13, 2014

    Report

    Report Number
    2031172-2014-00078
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 16, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K080238
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED ON (B)(4) 2014 TO THE MFR FOR EVAL. ONCE THE INVESTIGATION ON THE UNIT IS PERFORMED, A FOLLOW UP REPORT WILL BE SUBMITTED. INFO WAS PROVIDED TO MASIMO THAT THE NEWBORN PT IS BACK HOME WITH HIS PARENTS NOW WITHOUT ANYMORE PROBLEMS REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE RADICAL-7 HAD AN ISSUE WITH MEASURING SPO2 IN A MATERNITY AND NEONATES DEPT. THE RADICAL-7 WAS NOT ABLE TO DISPLAY A VALUE FOR SPO2 WHEN IT WAS PLACED ON A NEWBORN. THE BABY WENT THROUGH A DIFFICULT DELIVERY AND WAS DIAGNOSED WITH POOR HEALTH. HE WAS PLACED UNDER OXYGEN. THEY USE TO WORK WITH THE M-LNCS NEO (PN 2514). NONE OF THE DEVICES COULD GIVE SPO2 VALUE. THEN THEY TRANSFERRED THE BABY UNDER A PHILIPS MONITOR WITH A MASIMO CABLE AND SENSOR. THEY HAD A BRIEF VALUE DURING A FEW SECONDS AND THEN THERE WAS NONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351237 RADICAL-7 COLOR SCREEN HANDHELD DQA MASIMO CORPORATION RADICAL-7

    Patients

    Seq Age Sex Outcome Treatment
    1 PHILLIPS MONITOR