BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O2 SAT MONITOR

    MDR report key: 5130220 · Received October 6, 2015

    Report

    Report Number
    5130220
    Event Type
    Malfunction
    Date Received
    October 6, 2015
    Date of Event
    November 19, 2014
    Report Date
    September 18, 2015
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    I CAME IN THIS MORNING, TURNED ON THE MONITOR. MONITOR PERIODICALLY ALARMING THAT SPO2 LEVEL LOW WHEN NOT CONNECTED TO A PT. CLINICAL ENGINEERING CALLED, WHO CAME TO ASSESS THE MONITOR, MONITOR CONTINUING TO ALARM AT PERIODIC TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660350 O2 SAT MONITOR DQA

    Patients

    Seq Age Sex Outcome Treatment
    1