BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HANS RUDOLPH

    MDR report key: 22091 · Received March 28, 1995

    Report

    Report Number
    39748-1995-00001
    Event Type
    Injury
    Date Received
    March 28, 1995
    Date of Event
    January 27, 1995
    Report Date
    March 10, 1995
    Manufacturer
    HANS RUDOLPH, INC.
    Product Code
    JAX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL STAFF SPECIFICALLY REQUESTED SUBJECT DEVICE TO BE DELIVERED TO THEM FOR USE ON THE ABOVE PT, OUR REP. COMPLIED.HOSPITAL REPORTS INCREASED RESISTANCE TO VENTILATION RELATED TO SUBJECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANS RUDOLPH NON HEATED PNEUMOTACH JAX HANS RUDOLPH, INC. 8411A

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| L| R| S SIEMENS VENTILATOR-OTHER ITEMS UNKNOWN| VENTRAK RESPIRATORY MECHANICS MOBILE WORKSTATION