BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR PURITAN BENNETT NPB-40

    MDR report key: 3922476 · Received June 2, 2014

    Report

    Report Number
    2936999-2014-00463
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K963707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE THE SERIAL NUMBER FOR THIS UNIT, THEREFORE, THE DEVICE MANUFACTURER DATE IS UNK. (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT THAT THIS NPB40 PULSE OXIMETER IS MISSING DISPLAY SEGMENTS IN THE PULSE PORTION OF THE WINDOW. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320948 NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE OXIMETER DQA COVIDIEN, FORMERLY TYCO HEALTHCARE NPB-40

    Patients

    Seq Age Sex Outcome Treatment
    1