BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELIGHT

    MDR report key: 1883526 · Received October 19, 2010

    Report

    Report Number
    1883526
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 19, 2010
    Manufacturer
    NONIN MEDICAL, INC
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    THE FINGER CLIP IS BROKEN. THE RUBBER FINGER PROTECTOR IS SEPARATED FROM THE HARD, BLUE BACKING EXPOSING THE METAL SPRINGS AND THE WIRES. THESE ARE NEW AND THE THIRD ONE THAT HAS MALFUNCTIONED. NONE OF THEM HAVE BEEN IN USE FOR MORE THAN 3 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PURELIGHT REUSABLE SPO2 SENSORS DQA NONIN MEDICAL, INC 8000AA DC1008

    Patients

    Seq Age Sex Outcome Treatment
    1 *