Fabius Anesthesia Machine Recall Issued Due to Ventilation Failures

Federal health regulators say problems with Fabius anesthesia machines, which were recalled this summer, could cause patients to suffer serious health consequences or even death.  

This week the FDA determined that a Fabius anesthesia machine recall issued on August 14 constitutes a class 1 medical device recall, the most serious recall classification.

The manufacturer sent out an Urgent Medical Device recall letter to customers over the summer, warning about the potential risk of problems with the anesthesia machine. Although no injuries have been reported in association with the recalled product, the FDA suggests that continued use of the anesthesia machines carries a substantial risk of serious injury or death.

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The affected machines are used by licensed anesthesiologists to administer a safe pressure and flow of medical gases mixed with a predetermined concentration of anaesthetic vapour for putting a patient under during medical procedures. The affected machines may not have a minimum specified clearance between the electrical component and the unit housing, potentially causing bypass current flowing through the interior of the unit to cause the automatic ventilation function to fail.

The products included in the recall are Fabius GS Premium Anesthesia Machines, Fabius OS Anesthesia Machines, Fabius Tiro Anesthesia Machines, and Fabius Tiro D-M Anesthesia Machines manufactured by Draeger Medical Inc. of Telford, Pennsylvania from February 1, 2013 through May 1, 2013 where they were distributed for sale to licensed physicians and healthcare providers from March 1, 2013 to June 1, 2013.

For a full list of product codes and lots numbers of affected machines please visit https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=121287

The FDA considers “Class I” recalls the most dangerous because there is a reasonable probability that the use of the product will cause serious adverse health consequences including death.

Customers with affected machines should read the Urgent Medical Device Recall and use the manual ventilation mode in event of the automatic ventilation failure. Customers should also check their machines to verify if they are a part of the recall and contact Draeger Medical Customer Service Department at 1-800-543-5047 to schedule a replacement of the power supply.

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