BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR MODEL N-20

    MDR report key: 338346 · Received June 19, 2001

    Report

    Report Number
    8020893-2001-00007
    Event Type
    Malfunction
    Date Received
    June 19, 2001
    Report Date
    June 19, 2001
    Manufacturer
    NELLCOR PURITAN BENNETT IRE.
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ON THE 18TH MAY A NELLCOR PURITAN BENNETT EMPLOYEE RECEIVED INFORMATION REGARDING AN ISSUE WITH AN N20 PULSE OXIMETER. THE CUSTOMER ALLEGED "USUALLY READING 100% ON EVERYONE, SOMETIMES WILL SEE 99% BUT NOT OFTEN. CALLER STATES CALLER IS USUALLY AROUND 97% ON SELF AND CALLER IS SEEING 100% CONTINUOUS ON SELF WHILE IN EXTENDED MODE. CALLER STATES THE RATE WOULD CHANGE ON CALLER BUT NOT THE SAT.. CALLER STATES IN THE LAST COUPLE OF DAYS IT HAS READ 100% ON EVERYONE "IN THE HALLWAY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27937 NELLCOR MODEL N-20 PULSE OXIMETER DQA NELLCOR PURITAN BENNETT IRE. N-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *