BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR PURITAN BENNET NPV-40

    MDR report key: 3850850 · Received February 11, 2014

    Report

    Report Number
    2936999-2014-00107
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 21, 2014
    Report Date
    January 21, 2014
    Manufacturer
    COVIDIEN/FORMERLY TYCO
    Product Code
    DQA
    PMA / PMN Number
    K963707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE NPB40 DISPLAY WAS MISSING SEGMENTS ON THE FIRST DIGIT OF THE SATURATION OF PERIPHERAL OXYGEN (SPO2) READING. THE FAILURE HAPPENED WHEN THE DEVICE WAS NOT BEING USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90110 NELLCOR PURITAN BENNET NPV-40 HANDHELD PULSE OXIMETER DQA COVIDIEN/FORMERLY TYCO NPB-40

    Patients

    Seq Age Sex Outcome Treatment
    1