Events

Recall of R100 VENTILATOR SYSTEM - DIAPHRAGM CHAMBER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by METRAN CO. LTD..

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
    137838
  • Event Risk Class
    II
  • Event Initiated Date
    2013-11-27
  • 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
    One report received of the actuation of ventilator alarm and buzzing sound after 16 hrs of patient oscillation in a hospital in germany. the reason was a failure in the bonding of the diaphragm chamber producing leakage.

Device

R100 VENTILATOR SYSTEM - DIAPHRAGM CHAMBER
  • Model / Serial
    Model Catalog: 10010410001 (Lot serial: N/A)
  • Product Description
    R100 Ventilator System
  • Manufacturer
    METRAN CO. LTD.

Manufacturer

METRAN CO. LTD.
  • Manufacturer Address
    KAWAGUCHI-SHI
  • Manufacturer Parent Company (2017)
    Metran Co. Ltd.
  • Source
    HC