BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONIN

    MDR report key: 13964558 · Received March 31, 2022

    Report

    Report Number
    13964558
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    February 23, 2022
    Report Date
    February 24, 2022
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    USING NEW CONTINUOUS PULSE OX SENSORS MODEL 7000A. STAFF HAVE BEEN NOTICING THAT HE SENSORS ARE NOT ACCURATELY READING O2 LEVELS. THEY OFTEN HAVE TO BE CHANGED AND STILL DO NOT READ ACCURATELY OR DO NOT PICK UP AT ALL. PATIENT WAS IN NUCLEAR MEDICINE AND THE TELEMETRY WAS READING AN OXYGEN LEVEL OF LOW 70'S TO 60'S THE PRIMARY NURSE WENT TO CHECK ON PATIENT AND UPON OBTAINING A OXYGEN LEVEL WITH A DYNA MAP MACHINE THE PATIENT WAS ACTUALLY 100% TELEMETRY WAS STILL READING 71%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872447 NONIN OXIMETER DQA NONIN MEDICAL, INC. 7000A

    Patients

    Seq Age Sex Outcome Treatment
    1 31025 DA Female