BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR N-550 PULSE OXIMETER

    MDR report key: 1202065 · Received October 15, 2008

    Report

    Report Number
    2936999-2008-00498
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 1, 2008
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RETURNED TO A COVIDIEN SERVICE CENTER FOR INVESTIGATION. THE PROBLEM WAS CONFIRMED AND ISOLATED TO THE SPEAKER. THE SPEAKER WAS FOUND DAMAGED WITH A CUT COIL, AND THE CAUSE OF THIS DAMAGE IS UNK.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT OF A N-550 THAT WOULD NOT ALARM. THE UNIT WAS IN USE WITH A PT WHEN THE CONDITION WAS FOUND, AND THERE WAS NO HARM TO THE PT. CUSTOMER REPORTS HE IS NOT ABLE TO GET ANYMORE INFO FROM END-USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NELLCOR N-550 PULSE OXIMETER PULSE OXIMETER DQA NELLCOR PURITAN BENNETT N-550

    Patients

    Seq Age Sex Outcome Treatment
    1