BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEMS MODEL 700-A

    MDR report key: 819050 · Received February 13, 2007

    Report

    Report Number
    MW1041956
    Event Type
    Malfunction
    Date Received
    February 13, 2007
    Date of Event
    February 12, 2007
    Report Date
    February 13, 2007
    Manufacturer
    SOUTHEASTERN MEDICAL
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ITEM WAS MALFUNCTIONING. AFTER FURTHER INSPECTION, THE PRODUCT DOES NOT HAVE A FDA APPROVAL BUT REQUIRES ONE. THE LISTED VENDOR IS SELLING A MEDICAL DEVICE WITHOUT FDA APPROVAL. ITEM CAN BE FOUND ON THE FOLLOWING WEBSITE. HTTP://WWW.SEMEDICALSUPPLY.COM/PULSE_OXIMETE RS.HTM. SOUTHEASTERN MEDICAL SUPPLY, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEMS MODEL 700-A PULSE OXIMETER DQA SOUTHEASTERN MEDICAL MODEL 700-A *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR