BEUDAMED
    FDA Adverse Event Death Summary report: N

    NELLCOR PEDI-CAP END-TIDAL CO2 DETECTOR

    MDR report key: 52437 · Received November 27, 1996

    Report

    Report Number
    8043756-1996-00024
    Event Type
    Death
    Date Received
    November 27, 1996
    Date of Event
    September 16, 1996
    Report Date
    November 27, 1996
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    CCK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT, ADMITTED TO THE ER AND UNDERGOING CPR FOR A DROWNING ACCIDENT, BECAME DIFFICULT TO VENTILATE. THE DIFFICULTY (RESISTANCE TO FLOW) WAS ISOLATED TO THE CO END TIBAL CO2 DETECTOR WHICH HAD BECOME CONTAMINATED WITH PULMONARY EDEMA FLUID. THE CONTAMINATED DEVICE WAS REPORTEDLY CHANGED RESUSCITATION EFFORTS CONTINUED, HOWEVER, THE PT EVENTUALLY EXPIRED. ACCORDING TO THE DR, THE DEVICE WAS NOTED TO BE CONTAMINATED WITH PULMONARY EDEMA FLUID IN THE AMBULANCE, PRIOR TO ARRIVING AT THE ER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NELLCOR PEDI-CAP END-TIDAL CO2 DETECTOR END-TIDAL CO2 DETECTOR CCK NELLCOR PURITAN BENNETT PEDI-CAP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Death MAPLESON E CIRCUIT| JACKSON REES ATTACHMENT