BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-595 PULSE OXIMETER

    MDR report key: 1063565 · Received June 18, 2008

    Report

    Report Number
    2936999-2008-00303
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 30, 2008
    Report Date
    May 30, 2008
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS OPTED TO NOT RETURN THE UNIT IN FOR EVAL. THE CUSTOMER ISOLATED THE FAILURE TO THE SPEAKER. PREVIOUS SIMILAR INVESTIGATIONS HAVE ISOLATED THE PROBLEM TO AN OPEN CIRCUIT. IF ADD'L INFO IS MADE AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    COVIDIEN FORMERLY TYCO HEALTHCARE RECEIVED A REPORT FROM A BIOMEDICAL ENGINEER THAT THE UNIT DID NOT PROVIDE AN AUDIO TONE. THERE WAS 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 TYCO HEALTHCARE N-595

    Patients

    Seq Age Sex Outcome Treatment
    1