Background
The Sigma Elite was produced by Penlon in the year of 1994. The device is used as an anesthesia vaporizer. This device uses sevoflurane, a particular type of anesthetic used to put people to sleep before surgery. Its' main function is to supply the right amount of sevoflurane into the fresh gas supply. Fresh gas supply, referring to the combination of medical gasses and anesthetic agents being produced by the machine the device is connected to. This device has one known occurrence of error, due to a vaporizer leak. The leak went undetected prior to the surgery it was used in, but nobody was harmed due to the error. The case report that was filed about this incident chalked the leak up to, unfamiliarity with the product, vaporizer design, anesthesia machine design (Ohmeda Modulus II), use of a non-Ohmeda product on an Ohmeda machine, and the limitations of the 1993 FDA Anesthesia Apparatus Checkout Recommendations.
Penlon Sigma Elite (Unexpected Vaporizer Leak)
Identification
The Sigma Elite is identified by the name being printed on the front of the device, along with the company name Penlon. There is a diamond-shaped logo that accompanies the company name. There are markings on the top of the device that say "Read Manual Before Use". There are also arrows on the top of the device indicating whether the flow to the patient is going in or out. These devices can usually come in brighter colors such as, highlighter yellow, bright pink, and bright orange. The model number for this device is often located on the back of the device (Model Number: K942545).
Technical Specifications
- Weight: 16.1 lbs
- Dimensions: 21.7 cm x 12 cm x 19.4 cm (HXWXD)
- Liquid Capacity: 300 mL
- Flow Range: 0.2 to 15 L/min
- Concentration Range: 0.2 to 8 vol.%
- Filling System: Keyed or Screw Top Filler
- Source: Soma Technology (Penlon Sigma Elite Guide)