BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR PURITAN BENNETT NPB-40

    MDR report key: 2770161 · Received October 1, 2012

    Report

    Report Number
    2936999-2012-00454
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    July 1, 2012
    Report Date
    July 20, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K963707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THE UNIT IS MISSING DISPLAY SEGMENT, THE FAR RIGHT DIGIT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1