BEUDAMED
    FDA Adverse Event Death Summary report: N

    NELLCOR PURITAN BENNETT NPB-190 PULSE OXIMETER

    MDR report key: 442810 · Received February 19, 2003

    Report

    Report Number
    2936999-2002-00039
    Event Type
    Death
    Date Received
    February 19, 2003
    Date of Event
    October 21, 2002
    Report Date
    February 14, 2003
    Manufacturer
    NEW MERVUE IND PARK
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD EXPIRED IN THE HOME WHILE BEING MONITORED WITH A NPB190 PULSE OXIMETER. THE PULSE OXIMETER DISPLAYS REPORTED ZEROS AT THE TIME OF THE EVENT. THERE WAS NO INFO REGARDING THE ALARM STATUS. THERE WAS NO ALLEGATION OF A PROBLEM WITH THE PULSE OXIMETER. THE MONITOR WAS RETURNED FOR EVALUATION, AND ALL ALARM FUNCTIONS WERE CONFIRMED TO BE FUNCTIONAL. THE DEVICE WAS SET FOR DEFAULT ALARM VALUES, AND THE ALARM SILENCE REMINDER WAS SET TO ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NELLCOR PURITAN BENNETT NPB-190 PULSE OXIMETER PULSE OXIMETER DQA NEW MERVUE IND PARK NPB-190 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death| O