BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N595 PULSE OXIMETER

    MDR report key: 939046 · Received November 6, 2007

    Report

    Report Number
    2936999-2007-00470
    Event Type
    Malfunction
    Date Received
    November 6, 2007
    Date of Event
    October 1, 2007
    Report Date
    October 10, 2007
    Manufacturer
    GALWAY
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS REQUESTED BACK FOR INVESTIGATION, BUT IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    ON 10/10/2007, A BIOMEDICAL ENGINEER CALLED IN TO REPORT THAT THE UNIT HAD BEEN DROPPED WHICH RESULTED IN NO AUDIO. THE CUSTOMER CALLED BACK ON 10/16/2007 INDICATING THE UNIT WAS REPAIRED IN HOUSE AND NOW FUNCTIONING PROPERLY HOWEVER, THE SPEAKER WAS REPLACED AND THE UNIT WAS STILL NOT PROVIDING A AUDIO TONE. THE CUSTOMER COULD NOT CONFIRM IF THE NO AUDIO TONE WAS A RESULT OF THE DROP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N595 PULSE OXIMETER PULSE OXIMETER DQA GALWAY N595

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR