BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N-395 PULSE OXIMETER

    MDR report key: 1844836 · Received September 22, 2010

    Report

    Report Number
    2936999-2010-01206
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 13, 2010
    Manufacturer
    COVIDIEN - FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K991823
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNING OF THE DEVICE FOR FAILURE INVESTIGATION HAS BEEN REQUESTED. NO VALID SERIAL NUMBER WAS PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT ALLEGING THAT DEVICE DID NOT PROVIDE AUDIO TONE. THERE WAS NO PATIENT INCIDENT.

    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