BEUDAMED
    FDA Adverse Event Summary report: N

    RADICAL-7 HANDHELD

    MDR report key: 4093251 · Received September 5, 2014

    Report

    Report Number
    2031172-2014-00179
    Date Received
    September 5, 2014
    Date of Event
    July 20, 2014
    Report Date
    August 8, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K120657
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RADICAL 7 INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE RETURNED DEVICE PASSED ALL TESTING INCLUDING A VISUAL INSPECTION AND FUNCTIONAL TESTING WITH A KNOWN GOOD SENSOR. THE RETURNED DEVICE WAS CONFIRMED TO BE FUNCTIONING AS DESIGNED. ATTEMPTS FOR THE RETURN OF THE SENSOR AS WELL AS ADDITIONAL INFORMATION REQUESTS HAVE BEEN MADE IN ORDER TO IDENTIFY THE SENSOR INVOLVED IN THE REPORTED EVENT. AS OF THE DATE OF THIS REPORT, THE SENSOR HAS NOT BEEN RECEIVED BY MASIMO TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. IF NEW INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE "MACHINE SHOWS READING EVEN THE PROBE WAS NOT TIED IN THE BABY'S HAND (OR) FOOT. EVEN DIED BABY'S IT SHOWS READING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543251 RADICAL-7 HANDHELD DQA MASIMO CORPORATION 9500

    Patients

    Seq Age Sex Outcome Treatment
    1 Death