BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR PURITAN BENNET NPB-40

    MDR report key: 3102303 · Received April 30, 2013

    Report

    Report Number
    2936999-2013-00298
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K963707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THE UNIT'S DISPLAY WAS MISSING SEGMENTS IN THE SPO2 READINGS. NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188109 NELLCOR PURITAN BENNET NPB-40 HANDHELD PULSE OXIMETER DQA COVIDIEN, FORMERLY TYCO HEALTHCARE NPB-40

    Patients

    Seq Age Sex Outcome Treatment
    1