BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 2960509 · Received January 24, 2013

    Report

    Report Number
    2936999-2013-00046
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN CONFIRMED THE REPORTED PROBLEM AND ISOLATED THE FAILURE TO THE MAIN PCB. DAMAGE TO THE CASES OF THE UNIT WAS ALSO FOUND, THEREFORE, CUSTOMER DECLINED REPAIR AND THE UNIT WAS DISPOSED.

    Description of Event or Problem · 1

    COVIDIEN REC'D A REPORT THAT THE SPEAKER IS TOO QUIET. NO PT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34195 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DQA NELLCOR PURITAN BENNETT N-560

    Patients

    Seq Age Sex Outcome Treatment
    1