BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR OXIMAX N-600X PULSE OXIMETER

    MDR report key: 1961578 · Received December 23, 2010

    Report

    Report Number
    2936999-2010-01405
    Event Type
    Malfunction
    Date Received
    December 23, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 29, 2010
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K060576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CALLER HAS DECLINED RETURNING THE DEVICE FOR EVALUATION. THE SERIAL NUMBER WAS PROVIDED AND THE SERVICE HISTORY RECORD FOR THIS DEVICE WAS REVIEWED FOR SIMILAR COMPLAINT MODES. NO RELEVANT COMPLAINT MODES WERE FOUND IN THE DEVICE SERVICE HISTORY RECORD. IF THE DEVICE IS RETURNED AT A LATER DATE, THE COMPLAINT WILL BE REOPENED FOR INVESTIGATION. INFORMATION HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE DEVICE DID NOT ALARM WHEN PATIENT SATURATION DROPPED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1