BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PURELIGHT SENSORS

    MDR report key: 1879097 · Received October 6, 2010

    Report

    Report Number
    1879097
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 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

    WE HAVE JUST STARTED USING THE NONIN MODEL 8000AA ADULT FINGER CLIP. ON ONE DEVICE, THE SPRING ON THE INSIDE OF THE CLIP WAS DETACHED FROM THE PROTECTIVE RUBBER COVERING EXPOSING IT TO POTENTIALLY INJURING THE FINGER. ON THE OTHER DEVICE, THE 7 PINS THAT PLUGS INTO THE MACHINE ARE BENDING EASILY AND WILL NOT FIT. WE HAVE JUST RECEIVED THIS BATCH OF OXIMETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PURELIGHT SENSORS REUSABLE SPO2 SENSOR DQA NONIN MEDICAL, INC 8000AA ADULT FINGER CLIP *
    2 PURELIGHT SENSORS REUSABLE SPO2 SENSOR DQA NONIN MEDICAL INC 8000AA ADULT FINGER CLIP *

    Patients

    Seq Age Sex Outcome Treatment
    1 *