BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR N20PA

    MDR report key: 2854490 · Received November 29, 2012

    Report

    Report Number
    2936999-2012-00623
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 29, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K952222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAULT WAS ISOLATED TO THE LCD DISPLAY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THE UNIT HAD A PROBLEM WITH THE SCREEN. DURING INVESTIGATION IT WAS FOUND THAT THE DISPLAY OF THE UNIT HAD MISSING SEGMENTS. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NELLCOR N20PA PORTABLE PULSE OXIMETER DQA COVIDIEN, FORMERLY TYCO HEALTHCARE N-20PA

    Patients

    Seq Age Sex Outcome Treatment
    1