Fabius Anesthesia Machines: Recall - Did Not Pass High Voltage Test Portion Of Final Production Test
UPDATED 10/23/2013 with FDA Class 1 Recall Notice
[Originally Posted 10/08/2013]
AUDIENCE: Risk Manager, Anesthesiology, Critical Care Medicine
ISSUE: Dräger issued a statement regarding its voluntary recall on specific Fabius anesthesia machines. Investigations determined that on some power supply units from a particular batch, the required minimum clearance between an electrical component and the unit housing was not maintained. In extreme cases, the influence of mechanical forces, such as movement of the device, for example, may cause a failure of the automatic ventilation function of the device. If such a fault occurs, an audible and visual alarm is generated. Manual ventilation using the device is still possible and all other device functions remained unaffected. To date, there have been no reported injuries or reported failures due to this issue.
BACKGROUND: This recall affected 99 Fabius GS Premium, 9 Fabius OS, 43 Fabius Tiro, and 1 Fabius Tiro D-M anesthesia machines manufactured between February 2013 and May 2013 and distributed in the United States between March 2013 and June 2013. Affected devices were distributed nationally (see firm press release for information on affected serial numbers by model).
RECOMMENDATION: If users of the Fabius anesthesia machines experience such a failure of the automatic ventilation function, they should switch over to the manual ventilation mode by pressing the “Man/Spont” key, confirm with the rotary knob, and start manual ventilation. Additional details concerning switching to manual ventilation in case of a fault are provided in the Instructions for Use in the Fault-Cause-Remedy and Ventilator Fail Safe sections. Hospitals are urged to notify their personnel accordingly.
For questions regarding the operation and/or servicing of affected Dräger anesthesia machines in the United States, call DrägerService Technical Support at 1-800-543-5047 (press 4 at the prompt) between the hours of 8AM to 8PM EST Monday through Friday, or contact Dräger by e-mail at email@example.com.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[10/07/2013 - Firm Press Release- Drager]
[10/23/2013 - Recall Notice - FDA]