BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 2013562 · Received February 2, 2011

    Report

    Report Number
    2936999-2011-00039
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 10, 2011
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    PMA / PMN Number
    K021090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN EVAL FOUND THROUGH VISUAL EXAMINATION THAT THE BLACK WIRE OF THE SPEAKER ASSEMBLY WAS CUT RESULTING IN A LOSS OF AUDIO FUNCTION. THE CUT WAS LOCATED BETWEEN THE FRONT PANEL BRACKET AND THE BATTERY HOUSING.

    Description of Event or Problem · 1

    COVIDIEN REC'D A REPORT OF A N-560 THAT HAD NO AUDIO. THE N-560 DID NOT SOUND POWER ON SELF TEST (POST). CUSTOMER REPORTS THAT IT OCCURRED A WEEK PRIOR AND THAT THERE WAS NO PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1