BEUDAMED
    FDA Adverse Event Death Summary report: N

    NELLCOR PURITAN BENNETT

    MDR report key: 963111 · Received December 11, 2007

    Report

    Report Number
    2936999-2007-00520
    Event Type
    Death
    Date Received
    December 11, 2007
    Date of Event
    October 13, 2007
    Manufacturer
    NEW MERVUE INDUSTRIAL PARK
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR CLINICAL SPECIALIST CONTACTED THE BIOTECH WHO FILED THE REPORT. THE BIOTECH STATED THAT THE NPB290 WOULD NOT BE RETURNED TO THE MFR AT THIS TIME; HOWEVER, HE WAS ABLE TO SEND A COPY OF THE TREND DOWNLOAD INFO WHICH IS CURRENTLY UNDER REVIEW. IN ADDITION, THE BIOTECH STATED THAT THE ALARMS ON THE NPB290 WERE FUNCTIONING. THE REPORT IS CURRENTLY UNDER INVESTIGATION. WHEN SIGNIFICANT NEW INFO IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IN 2007 NELLCOR PURITAN BENNETT REC'D A COPY OF A REPORT. THE FIRST PAGE LISTS ANOTHER MANUFACTURER'S VENTILATOR AS SUSPECT DEVICE. THE EVENT DESCRIPTION STATES THE PT WAS FOUND DECANNULATED AND UNRESPONSIVE AND THE VENTILATOR AND PULSE OXIMETER DID NOT ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NELLCOR PURITAN BENNETT PULSE OXIMETER DQA NEW MERVUE INDUSTRIAL PARK N290 *

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Death