BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR

    MDR report key: 2850007 · Received November 27, 2012

    Report

    Report Number
    2850007
    Event Type
    Malfunction
    Date Received
    November 27, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 27, 2012
    Manufacturer
    COVIDIEN
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REMANUFACTURED PROBE WOULD NOT WORK WHEN PLUGGED IN UPON STARTING MONITORING. NO LIGHT SENSOR. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NELLCOR OXIMETER DQA COVIDIEN * 2146070X

    Patients

    Seq Age Sex Outcome Treatment
    1 *