BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-595 PULSE OXIMETER

    MDR report key: 3063375 · Received April 11, 2013

    Report

    Report Number
    2936999-2013-00282
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. THE CUSTOMER WAS AWARE THE DEVICE HAS REACHED HAS END OF LIFE. CUSTOMER WAS PROVIDED PRICING FOR REPLACEMENT. NO FURTHER CONCLUSIONS CAN BE DRAWN BY THE MANUFACTURING SITE SINCE THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. INFORMATION HAS BEEN ADDED TO THE DATABASE AND COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT THAT THE UNIT DOES NOT HAVE ANY AUDIO. THE ISSUE WAS NOTICED DURING SETUP BEFORE USE ON PATIENT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156287 OXIMAX N-595 PULSE OXIMETER PULSE OXIMETER DQA COVIDIEN, FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1