Events

Recall of INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE - BABYLOG VN500

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by DRAEGER MEDICAL CANADA INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    22631
  • Event Risk Class
    II
  • Event Initiated Date
    2010-12-23
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Drager had been informed about one case in which the neonatal patient was not adequately ventilated in high frequency oscillation (hfo) ventilation mode. the patient desaturated no permanent patient injury occured. investigations have shown that the instability of the mean airway pressure caused insufficient gas exchange resulting in the desaturation of the patient.

Device

INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE - BABYLOG VN500
  • Model / Serial
    Model Catalog: 8415000 (Lot serial: ASBL-0049); Model Catalog: 8415000 (Lot serial: ASBL-0035); Model Catalog: 8415000 (Lot serial: ASBL-0034); Model Catalog: 8415000 (Lot serial: ASBL-0033); Model Catalog: 8415000 (Lot serial: ASBL-0065); Model Catalog: 8415000 (Lot serial: ASBL-0067); Model Catalog: 8415000 (Lot serial: ASBL-0064); Model Catalog: 8415000 (Lot serial: ASBL-0066); Model Catalog: 8415000 (Lot serial: ASBL-0045); Model Catalog: 8415000 (Lot serial: ASBL-0043); Model Catalog: 8415000 (Lot serial: ASBL-0050); Model Catalog: 8415000 (Lot serial: ASBL-0046); Model Catalog: 8415000 (Lot serial: ASBL-0044); Model Catalog: 8415000 (Lot serial: ASBL-0051); Model Catalog: 8415000 (Lot serial: ASBL-0039); Model Catalog: 8415000 (Lot serial: ASBL-0037); Model Catalog: 8415000 (Lot serial: ASBL-0040); Model Catalog: 8415000 (Lot serial: ASBL-0042); Model Catalog: 8415000 (Lot serial: ASBL-0047); Model Catalog: 8415000 (Lot serial: ASBL-0041); Model Catalog: 8415000 (Lot serial: ASBL-0038); Model Catalog:
  • Product Description
    VENTILATION NEONATAL UNIT
  • Manufacturer
    DRAEGER MEDICAL CANADA INC.

Manufacturer

DRAEGER MEDICAL CANADA INC.