BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAD-87

    MDR report key: 4749924 · Received May 1, 2015

    Report

    Report Number
    2031172-2015-00728
    Event Type
    Injury
    Date Received
    May 1, 2015
    Date of Event
    November 13, 2014
    Report Date
    April 3, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT INVOLVED IN THIS EVENT HAS NOT BEEN RETURNED TO DATE TO ALLOW FOR AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS IS A FOLLOW UP TO THE USER FACILITY REPORT SUBMITTED AND RECEIVED BY MASIMO. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATES "THE BABY NEEDED CPAP TO ASSIST WITH HIS VENTILATION. THE PULSE OXIMETER WAS PLACED AND WE WERE UNABLE TO GET AN ACCURATE SATURATION UNTIL AFTER 7 MINUTES OF RESUSCITATION. ONGOING HISTORY WITH MALFUNCTIONS OF THE RAD 57- RAD 87."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289333 RAD-87 OXIMETER DQA MASIMO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention