BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTILATOR, PEDIATRIC (GENERAL)

    MDR report key: 223216 · Received May 14, 1999

    Report

    Report Number
    2020676-1999-00001
    Event Type
    Death
    Date Received
    May 14, 1999
    Date of Event
    April 13, 1999
    Report Date
    May 14, 1999
    Manufacturer
    SECHRIST INDUSTRIES, INC.
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPANY'S DISTRIBUTOR REPORTED A PROBELM REGARDING ONE OF THEIR INFANT VENTILATORS, MODEL IV-100B, IN USE IN PARAGUAY. THE DISTRIBUTOR NOTED THE MANOMETER WAS SHOWING 25CMH20 LESS RESPIRATORY PRESSURE THAN WHAT WAS ACTUALLY DELIVERED TO THE PATIENT. THE DISTRIBUTOR HAD RETURNED ONLY THE MANOMETER P/N IV303-01A FOR EVALUATION. THE USER FACILITY ORIGINALLY REPORTED THE VENTILATOR MAY HAVE BEEN INVOLVED IN THE DEATH OF 3 INFANTS DUE TO PNEUMOTHORAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTILATOR, PEDIATRIC (GENERAL) ALL CONFIGURATIONS CBK SECHRIST INDUSTRIES, INC. IV-100B *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death HOSP REFUSED TO RELEASE ANY INFO REGARDING| TREATMENT OF THE 3 INFANTS.