BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAD 87

    MDR report key: 4278584 · Received November 18, 2014

    Report

    Report Number
    MW5039244
    Event Type
    Other
    Date Received
    November 18, 2014
    Date of Event
    November 13, 2014
    Report Date
    November 18, 2014
    Manufacturer
    MASIMO
    Product Code
    DQA
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    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
    745633 RAD 87 PULSE OXIMETER DQA MASIMO

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA