BEUDAMED
    FDA Adverse Event Death Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 2438163 · Received February 1, 2012

    Report

    Report Number
    2936999-2012-00028
    Event Type
    Death
    Date Received
    February 1, 2012
    Date of Event
    December 23, 2011
    Report Date
    January 5, 2012
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    PMA / PMN Number
    K021090
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS INSPECTED ON (B)(6) 2011 BY (B)(4), DISTRIBUTOR OF UNIT, PRIOR TO RETURN TO COVIDIEN-(B)(4). COVIDIEN-(B)(4) TESTED THE N-560 AND THE DOC-10. TESTING CONDUCTED BY BOTH COVIDIEN AND THE DISTRIBUTOR CONCLUDED THE ALARM WORKED AS EXPECTED. THE DOC-10 FUNCTIONED AS EXPECTED. USING THE HYPERTERMINAL TREND DATA DOWNLOAD THE DATA STATUS INDICATED AN SPO2 ALARM CONDITION WAS GENERATED. NO SENSOR WAS RECEIVED. COVIDIEN HAS MADE MULTIPLE ATTEMPTS TO GET ADDITIONAL EVENT INFORMATION, HOWEVER, HAS BEEN UNABLE TO OBTAINED FURTHER DETAILS OF THE EVENT.

    Description of Event or Problem · 1

    CUSTOMER STATES: DURING USE OF THE N-560 ON A PATIENT, THE PATIENT'S FAMILY REPORTED NO ALARM WHEN SPO2 OR PULSE READING READ BETWEEN 30 AND 40 SATURATION. THE PATIENT: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DQA NELLCOR PURITAN BENNETT N-560

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Death FLOW VOLUME: 1L/MIN). A MAX-NJ SENSOR AND DOC-10| ARE BOTH COVIDIEN PRODUCT.| OXYGEN CONCENTRATOR - TERUMO KOHARU