BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-595 PULSE OXIMETER

    MDR report key: 1853837 · Received September 8, 2010

    Report

    Report Number
    2936999-2010-01173
    Event Type
    Malfunction
    Date Received
    September 8, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 10, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVAL. THE CUSTOMER REVEALED THAT THE SPEAKER ASSEMBLY WAS REPLACED AND THE UNIT STILL DID NOT PROVIDE AUDIO WHICH INDICATES FAILURE OF THE MAIN PCB. ADDITIONALLY, 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. THE CUSTOMER HAS DECLINED RETURNING THE DEVICE. INFO HAS BEEN ADDED TO THE DATABASE AND COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED.

    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 PT HARM REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1