BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAD 87

    MDR report key: 4278565 · Received November 18, 2014

    Report

    Report Number
    MW5039242
    Event Type
    Other
    Date Received
    November 18, 2014
    Date of Event
    November 14, 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

    UNIT B (B)(4) SATURATIONS WERE LIKELY APPROPRIATE BUT HR 54 CONSISTENTLY 54 ON VIGOROUS INFANT. ONGOING HISTORY OF EQUIPMENT MALFUNCTIONS WITH RAD 57- RAD 87.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745629 RAD 87 PULSE OXIMETER/MONITOR DQA MASIMO

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA