Events

Recall of eVent Medical Ltd

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Event Medical.

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
    33276
  • Event Risk Class
    Class 2
  • Event Number
    Z-0062-06
  • Event Initiated Date
    2005-08-12
  • Event Date Posted
    2005-10-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41591
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ventilator, Continuous, Facility Use - Product Code CBK
  • Reason
    Firm received reports of combustion within the blender system of the inspiration ventilator.
  • Action
    Customer shall be notified by an Urgent Product Safety Notfication letter dated August 12, 2005. The letter shall advise the customer with the specifics of this problem, summarise the fact that the hazard potential in negligible and will advise the customer regarding options for replacement of the Blender Module assembly (part number F710400) and the Air/O2 Filters (part number F910300). The letter will also provide the customers with a set of actions which can be completed immediately in order to ensure the integrity of their gas supplies until their unit has been upgraded.

Device

eVent Medical Ltd
  • Model / Serial
    All serial numbers for Models F7100000-XX, F7200000-XX, and F7300000-XX
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and Canada, Europe, Japan, Latin America, Asia/Pacific, Middle East
  • Product Description
    INSPIRATION Ventilator Model Numbers: F7100000-XX, F7200000-XX, F7300000-XX; where XX designates the language variant. IN = English (International); GB=English (US); FR= French; DE=German; IT=Italian; PT=Portuguese; ES=Spanish; JP=Japanese; PL=Polish; RU=Russian
  • Manufacturer
    Event Medical

Manufacturer

Event Medical
  • Manufacturer Address
    Event Medical, 2440 Grand Ave, Vista CA 92081-7829
  • Source
    USFDA