BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-595 PULSE OXIMETER

    MDR report key: 1052257 · Received May 23, 2008

    Report

    Report Number
    2936999-2008-00247
    Event Type
    Malfunction
    Date Received
    May 23, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 20, 2008
    Manufacturer
    COVIDIEN FORMERLY TYCOHEALTHCARE
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CALLER HAS DECLINED RETURNING THE DEVICE FOR EVALUATION. MANUFACTURING FACILITY HAS INITIATED A CORRECTIVE AND PREVENTATIVE ACTION ASSOCIATED WITH THE CUSTOMER REPORTED FAILURE.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED A REPORT FROM A BIOMEDICAL ENGINEER THAT THE UNIT DID NOT PROVIDE AN AUDIO TONE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1