BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPO2 OXIMETER FINGER PROBE

    MDR report key: 16033289 · Received December 22, 2022

    Report

    Report Number
    16033289
    Event Type
    Malfunction
    Date Received
    December 22, 2022
    Date of Event
    December 9, 2022
    Report Date
    December 14, 2022
    Manufacturer
    ITAMAR MEDICAL INC
    Product Code
    MNR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE PATIENT COMPLETED A HOME SLEEP APNEA TEST AND INFORMED OUR DESK STAFF ABOUT THE PRESSURE AND BURNING FEELING WITH THE OXIMETER FINGER PROBE. THE PATIENT WOKE UP MULTIPLE TIMES AND FELT LIKE SHE WAS BEING SHOCKED OR SOMETHING. IT WAS NOT ALL NIGHT, BUT IT WAS LIKE PULSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2840179 SPO2 OXIMETER FINGER PROBE VENTILATORY EFFORT RECORDER MNR ITAMAR MEDICAL INC UNI1500677

    Patients

    Seq Age Sex Outcome Treatment
    1 14235 DA Female