BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR N595 PULSE OXIMETER

    MDR report key: 751792 · Received October 27, 2005

    Report

    Report Number
    2936999-2005-00450
    Event Type
    Malfunction
    Date Received
    October 27, 2005
    Date of Event
    October 1, 2005
    Report Date
    October 25, 2005
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS REQUESTED BACK FOR EVALUATION, BUT HAS NOT BEEN RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NELLCOR PURITAN BENNETT ON 10/25/2005 FROM A BIOMEDICAL ENGINEER THAT FOLLOWING THE SPEAKER UPGRADE THE UNIT PROVIDED NO AUDIO. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NELLCOR N595 PULSE OXIMETER PULSE OXIMETER DQA NELLCOR PURITAN BENNETT N-595 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other