Events

Safety Alert for Tec 6 and Tec 6 Plus Vaporizers

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by GE Healthcare.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-08-13
  • Event Date Posted
    2013-08-13
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130813.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: ge healthcare tec 6 and tec 6 plus vaporizers medical device manufacturer, ge healthcare issued a medical device safety alert concerning all tec 6 and tec 6 plus vaporizers. according to the ge healthcare, the user manual pre-operative check, low pressure leak test at 1% dial setting may not detect the full range of leaks from seal wear degradation in the vaporizers. moreover, the integrity of the vaporizer seal may be affected with tec 6 or tec 6 plus vaporizer remanufactured/ manufactured between 12 aug 2005 and 3 dec 2012, due to wear degradation. for any tec 6 or tec 6 plus vaporizer remanufactured / manufactured between 12 aug 2005 and 3 dec 2012 (aetj29001 to aesr49001), a ge healthcare service representative will schedule a repair to update the vaporizer seal. the leak test failures will get first priority for scheduling repair/replacement the manufacturer advises that the addendum with the field safety notice distributed to the affected users had the 12% low pressure leak test which will aid in determining the integrity of the seal. the manufacturer also provides the following recommendations to the affected users: update the tec 6 and tec 6 plus vaporizers user manual with the addendum given. perform the user manual recommended pre-operative check which includes the low pressure leak test on every vaporizer with the dial turned to the 12% setting instead of the specified 1% setting. discontinue use of the tec 6 or tec 6 plus vaporizer if it does not pass the new low pressure leak at 12%, remove it from service and contact a ge healthcare representative for a repair/replacement. if the vaporizer passes the new low pressure leak test at the 12 % setting, it can be used, however, as detailed in the user manual, users should continue to routinely perform the pre-operative check which includes the low pressure leak test. use a monitor to measure the oxygen and anesthetic agent levels as well as monitoring the bellows position during the use of any anesthesia system. according to the local supplier, the affected products have been distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 august 2013.

Device

Tec 6 and Tec 6 Plus Vaporizers
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: GE Healthcare Tec 6 and Tec 6 Plus Vaporizers
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare