BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-595 PULSE OXIMETER

    MDR report key: 1842057 · Received August 20, 2010

    Report

    Report Number
    2936999-2010-01123
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 22, 2010
    Manufacturer
    COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. THE SERVICE HISTORY RECORD FOR THIS DEVICE WAS REVIEWED FOR SIMILAR COMPLAINT MODES. NO RELEVANT COMPLAINT MODES WERE FOUND IN THE DEVICE SERVICE HISTORY RECORD. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED. INFORMATION HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED A REPORT FROM A BIOMEDICAL ENGINEER THAT THE UNIT DID NOT PROVIDE AN AUDIO TONE. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXIMAX N-595 PULSE OXIMETER PULSE OXIMETER DQA COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1