FDA MedWatch - BCI Remote Alarm Cables By Smith's Medical ASD, Inc.: Class 1 Recall - Cables Are Not Transferring Alarms

["FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - BCI Remote Alarm Cables By Smith's Medical ASD, Inc.: Class 1 Recall - Cables Are Not Transferring Alarms

BCI Remote Alarm Cables By Smith's Medical ASD, Inc.: Class 1 Recall - Cables Are Not Transferring Alarms

AUDIENCE: Risk Manager, Health Professional

ISSUE: Smiths Medical has become aware that, in rare instances, the BCI Remote Alarm Cables (BCI Cables) are not transferring alarms when used with some remote nurse alarm systems. These products may cause serious adverse health consequences, including death.

BACKGROUND: The BCI Remote Alarm Cables are designed for use with the 9004 Capnocheck Capnography (Plus or Sleep) System to transfer alarm signals from the Capnocheck Capnography System to a remote alarm system. The BCI Remote Alarm Cables and the 9004 Capnocheck Capnography System are intended for use in all critical environments including ventilator applications, patient transport, and anesthesia on patients ranging from pediatric to adult.

RECOMMENDATION: On Feb. 6, 2013, Smiths Medical sent its customers an "Urgent Medical Device Field Safety Notice-Recall" letter by UPS and customers were instructed to:

• Inspect their inventory
• Remove all affected devices from use
• Complete and return the attached "Confirmation Form" by fax at 1-800-237-8033 or by email to BCIRemote.AlarmCable@xxxxxxxxxxxxxxxxxx.

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 complete MedWatch Safety Alert, including a link to the Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm347235.htm

 

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