BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3032663 · Received March 29, 2013

    Report

    Report Number
    2936999-2013-00242
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 20, 2013
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN ISOLATED THE FAILURE TO THE FRONT PCB. THE FRONT PCB HAS BEEN FORWARDED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT OF SOME MISSING DIGITS. THE COVIDIEN SERVICE CENTER DETERMINED THAT THERE WERE MISSING SEGMENTS OF THE DISPLAY. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130347 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DQA NELLCOR PURITAN BENNETT N-560

    Patients

    Seq Age Sex Outcome Treatment
    1