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FDA MedWatch Nellcor Puritan Bennett 980 Ventilator System Class I Recall

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Maquet Medical Systems USA FLOW-i Anesthesia System: Class 1 Recall - Device Field Correction

Wednesday, July 11, 2012

AUDIENCE: Risk Manager

ISSUE: FDA notified healthcare professionals of a Class I Recall of the Maquet Medical Systems USA FLOW-i Anesthesia System (software). A technical alarm may be generated on the FLOW-i system when using the Manual/Automatic (MAN/AUTO) switch to change ventilation modes from manual to automatic or from automatic to manual if the switch is not fully engaged in the "on" or "off" position but remains in between the two positions. Use of this product may cause serious adverse health consequences, including death.

The FLOW-i Anesthesia System was distributed from May 9, 2010 through December 29, 2011. See the Recall Notice for a listing of affected Model and Serial Numbers.

BACKGROUND: The FLOW-i Anesthesia System is intended to administer anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as supporting patients with a limited ability to breathe.

RECOMMENDATION: On February 20, 2012, the firm sent its customers an Urgent Device Field Correction notice. The firm informed their customers that their Maquet Service Representative will upgrade the software in their FLOW-i Anesthesia System to the current version and also provide them with the corresponding user manual.

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

Read the MedWatch safety alert, including a link to the Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm311471.htm

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