[Posted 02/25/2015]

AUDIENCE: Nursing, Risk Manager

ISSUE: Cracks were found in the connector tubes during the manufacturing process and some devices were distributed before the problem was identified. These cracks may cause oxygen and other gases to leak from the ventilator and prevent the device from delivering sufficient support to the patient. This may potentially cause serious injury or death.

Affected lot numbers are listed in the Recall Notice.

BACKGROUND: The MAQUET Servo Humidifier is a heat and moisture condenser that is placed over a surgically-created opening in the throat (tracheotomy) or a tube inserted into the trachea to warm and moisten gases breathed in by a patient.  The primary users of this device are nurses and respiratory therapists.

RECOMMENDATION:  INMED sent customers an Urgent - Field Safety Notice dated January 12, 2015. The notice identified the product, problem, and action to be taken.

Customers:

•Immediately check inventory.

•Quarantine and discontinue use of the device.

•Return the acknowledgement form sent with the notice back to Maquet within five days of receipt.

•Request a return authorization form from Maquet for the recalled devices.

Additionally, distributors were requested to:

•Immediately stop distributing the recalled device.

•Send the Urgent Field Safety Notice to customers.

•Request customers to complete the acknowledgement form sent with the notice within five days of receipt and return to you.

•Forward the completed acknowledgement forms back to Maquet.

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

[02/25/2015 - Recall Notice - FDA]