BEUDAMED
    FDA Adverse Event Death Summary report: N

    NELLCOR NPB-290 PULSE OXIMETER

    MDR report key: 485565 · Received September 26, 2003

    Report

    Report Number
    2936999-2003-00007
    Event Type
    Death
    Date Received
    September 26, 2003
    Report Date
    September 26, 2003
    Manufacturer
    NEW MERVUE IND. PARK
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RECEIVED REPORT THAT ALLEGES DURING A COMPLAINT FOLLOW UP, REPORTER HAD RECEIVED NOTICE THAT THE DECIBEL VOLUME OF A NPB-290 ALARM WAS LESS THAN 35 DB IN A PATIENT'S ROOM, THAT WAS CLAIMED TO BE INAUDIBLE. THIS INFORMATION WAS RECEIVED AS PART OF DOCUMENTATION IN A LAWSUIT. FURTHER INFORMATION INDICATED A PATIENT DEATH OCCURRED. IT CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED WHETHER THE PULSE OXIMETER MAY HAVE CONTRIBUTED OR CAUSED A PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NELLCOR NPB-290 PULSE OXIMETER PULSE OXIMETER DQA NEW MERVUE IND. PARK NPB-290 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death