BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-550 PULSE OXIMETER

    MDR report key: 2121951 · Received May 23, 2011

    Report

    Report Number
    2936999-2011-00347
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 25, 2011
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    PMA / PMN Number
    K021090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN SERVICE TECHNICIAN ISOLATED THE AUDIO FAILURE TO A CONNECTION AT THE MAIN PCB. THE MAIN PCB WAS REPLACED. THE CONNECTING SPEAKER WAS REPLACED AS A PRECAUTION, BUT IT WAS NOT A FAILED COMPONENT.

    Description of Event or Problem · 1

    COVIDIEN SERVICE CENTER IN (B)(4) RECEIVED A N-550 WHERE UPON REPAIR ON (B)(6) 2011, AN AUDIO FAILURE WAS DETERMINED. NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXIMAX N-550 PULSE OXIMETER PULSE OXIMETER DQA NELLCOR PURITAN BENNETT N-550 PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1