BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEI 12-1926 BASELINE FINGERTIP PULSE OXIMETER, STANDARD

    MDR report key: 13334232 · Received January 21, 2022

    Report

    Report Number
    MW5106902
    Event Type
    Malfunction
    Date Received
    January 21, 2022
    Date of Event
    January 19, 2022
    Report Date
    January 19, 2022
    Manufacturer
    FABRICATION ENTERPRISES INC.
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE BASELINE PULSE OXIMETER DISPLAY IS UPSIDE DOWN. A 98% BECOMES 89%. IT WAS AVAILABLE HERE: (B)(6). BASELINE FINGERTIP PULSE OXIMETER, STANDARD. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830254 FEI 12-1926 BASELINE FINGERTIP PULSE OXIMETER, STANDARD OXIMETER DQA FABRICATION ENTERPRISES INC. 12-1926 124617

    Patients

    Seq Age Sex Outcome Treatment
    1 Male