BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-595 PULSE OXIMETER

    MDR report key: 1172166 · Received September 17, 2008

    Report

    Report Number
    2936999-2008-00446
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 5, 2008
    Manufacturer
    COVIDIEN FORMERLY TYCO
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS OPTED TO NOT RETURN THE DEVICE IN FOR EVALUATION. THE CUSTOMER ISOLATED THE REPORTED PROBLEM OF NO AUDIO TO THE MAIN PCB BY SWAPPING WITH A GOOD KNOWN SPEAKER. IF ADDITIONAL INFO IS MADE AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE MANUFACTURING FACILITY HAS INITIATED A CORRECTIVE AND PREVENTATIVE ACTION ASSOCIATED WITH THE CONFIRMED FAILURE.

    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 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 TYCO N-595

    Patients

    Seq Age Sex Outcome Treatment
    1