BEUDAMED
    FDA Adverse Event Other Summary report: N

    OXIMAX N-600 PULSE OXIMETER

    MDR report key: 1290908 · Received December 3, 2008

    Report

    Report Number
    2936999-2008-00597
    Event Type
    Other
    Date Received
    December 3, 2008
    Date of Event
    October 1, 2008
    Report Date
    November 4, 2008
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TROUBLESHOOTING BETWEEN COVIDIEN TECHNICAL SUPPORT AND THE REPORTER REVEALED THAT THE PULSE OXIMETER ALARMS HAD BEEN SET TO OFF ON THE MONITOR SETUP; THEREFORE, AUDIBLE ALARMS WERE NOT HEARD ON THE CENTRAL STATION OR THE PULSE OXIMETER. THERE IS NO PRODUCT RETURNING TO COVIDIEN FOR INVESTIGATION, HOWEVER, A COVIDIEN TECHNICAL SUPPORT EMPLOYEE PERFORMED A TREND MEMORY DOWNLOAD AT THE HOSPITAL. A SUPPLEMENTAL REPORT WILL BE PROVIDED WITH THE TREND MEMORY ANALYSIS.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT WHERE IT WAS CLAIMED THAT A CHILD "CODED AND WAS MOVED TO ICU". THE REPORTER CLAIMED THAT THE CENTRAL STATION AND THE PULSE OXIMETER DID NOT ALARM. FURTHER TROUBLE SHOOTING REVEALED THAT THE VOLUME ON THE PULSE OXIMETER HAD BEEN SET TO OFF ON THE MONITOR SETUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXIMAX N-600 PULSE OXIMETER PULSE OXIMETER DQA COVIDIEN, FORMERLY TYCOHEALTHCARE N-600

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention