BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 2043053 · Received February 23, 2011

    Report

    Report Number
    2936999-2011-00107
    Event Type
    Malfunction
    Date Received
    February 23, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    PMA / PMN Number
    K021090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN ISOLATED THE FAILURE TO THE MAIN PCB.

    Description of Event or Problem · 1

    COVIDIEN SERVICE CTR IN NETHERLANDS RECEIVED A REPORT OF A N-560 FOR NO ALARM SOUND. NO PT HARM REPORTED.

    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