BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELCOR-10

    MDR report key: 73462 · Received March 5, 1997

    Report

    Report Number
    73462
    Event Type
    Malfunction
    Date Received
    March 5, 1997
    Date of Event
    March 4, 1997
    Report Date
    March 5, 1997
    Manufacturer
    NELCOR, INC.
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PROBE CONNECTION PIECE IS BROKEN THEREFORE NURSE IS UNABLE TO GET AN ACCURATE READING FROM PULSE OXIMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NELCOR-10 PULSE OXIMETER DQA NELCOR, INC. N10 01111021+ *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other BIOMEDICAL ENGINEERING DEPT RN EVALUATION| 030497 - LAST DATE OF USE. DEVICE SENT TO