Important Safety Alerts

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