BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N-395 PULSE OXIMETER

    MDR report key: 2110909 · Received February 23, 2011

    Report

    Report Number
    2936999-2011-00123
    Event Type
    Malfunction
    Date Received
    February 23, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 4, 2011
    Manufacturer
    COVIDIEN - FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K991823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT RETURNING FOR EVAL. THE SERVICE HISTORY FOR THE PROVIDED SERIAL NUMBER WAS REVIEWED AND THERE WERE NO SIMILAR COMPLAINTS RELEVANT TO THIS REPORT. THE COMPLAINT TRENDING FOR THE PAST 12 MONTHS WAS REVIEWED AND THERE WERE NO OBSERVED TRENDS RELATED TO THIS REPORT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO FROM THE REPORTING FACILITY. TO DATE, THERE HAS BEEN NO RESPONSE. THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A COPY OF MEDWATCH UF/IMPORTER REPORT (B)(4). DESCRIPTION OF THE EVENT: A PULSE OXIMETER DID NOT ALARM EITHER IN THE ROOM OR IN THE HALLWAY. DATE OF THE EVENT: WAS NOT SPECIFIED. A SEPARATED EVENT WAS REPORTED IN THE SAME UF REPORT (B)(4) AND IS FILE UNDER MFR. REPORT 2936999-2011-00122.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N-395 PULSE OXIMETER PULSE OXIMETER DQA COVIDIEN - FORMERLY TYCO HEALTHCARE N-395

    Patients

    Seq Age Sex Outcome Treatment
    1