BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N600 PULSE OXIMETER

    MDR report key: 1034886 · Received April 25, 2008

    Report

    Report Number
    2936999-2008-00209
    Event Type
    Malfunction
    Date Received
    April 25, 2008
    Date of Event
    February 21, 2008
    Report Date
    April 18, 2008
    Manufacturer
    COVIDIEN/ FORMERLY TYCOHEALTHCARE
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 04/18/2008, INFORMATION WAS RECEIVED FROM THE SERVICE SITE THAT THE UNIT WAS RECEIVED IN WITHOUT ANY FAILURE INFORMATION. MULTIPLE ATTEMPTS WERE MADE TO THE CUSTOMER TO TRY AND OBTAIN FAILURE INFORMATION, BUT NO RESPONSE WAS RECEIVED FROM THE CUSTOMER. THE SERVICE SITE PERFORMED AN INVESTIGATION ON THE UNIT, AND VERIFIED A FAILURE OF ERROR 517 WHICH ALSO AFFECTED THE AUDIO CIRCUIT, RESULTING IN "NO AUDIO" ON THE DEVICE. THE OBSERVED FAILURE OF "NO AUDIO" WAS ISOLATED TO THE MAIN PCB.

    Description of Event or Problem · 1

    ON 04/18/2008, NEW INFORMATION WAS RECEIVED FROM SERVICE SITE INDICATING THAT DURING REPAIR OF THE UNIT, NO AUDIO WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N600 PULSE OXIMETER PULSE OXIMETER DQA COVIDIEN/ FORMERLY TYCOHEALTHCARE N600

    Patients

    Seq Age Sex Outcome Treatment
    1