Events

Recall of NAVIGATOR ANESTHESIA DELIVERY SYSTEM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mindray DS USA, Inc., dba Datascope Patient Monitoring.

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
    49713
  • Event Risk Class
    Class 2
  • Event Number
    Z-0319-2009
  • Event Initiated Date
    2008-10-07
  • Event Date Posted
    2008-12-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-12-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74064
  • 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
    Anesthesia gas-machine - Product Code BSZ
  • Reason
    Two issues have been identified with the as3000 unit. 1. the threadlocker of the caster (wheels) may not have been utilized, which may allow the caster to loosen and possibly separate from the unit. 2. the use of select brands of pre-pack absorber in the absorber canister of the as3000 has been associated, in some cases, with gas leakage around the pre-pack, rather than through the absorber mate.
  • Action
    Notification (Urgent Product Field Correction) letters were sent to the one consignee on October 7, 2008 by Federal Express overnight delivery.

Device

NAVIGATOR ANESTHESIA DELIVERY SYSTEM
  • Model / Serial
    Serial Number: AN0804-001 and AN0804-006. Each AS3000 Anethesia Delivery System is labeled with a unique serial number.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Only 2 units are in distribution, both in the same facility in Redondo Beach, CA.
  • Product Description
    AS3000 Anesthesia Delivery System. Datascope Patient Monitoring; || A Mindray Global Company. || The AS3000 is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.
  • Manufacturer
    Mindray DS USA, Inc., dba Datascope Patient Monitoring

Manufacturer

Mindray DS USA, Inc., dba Datascope Patient Monitoring