Flight Medical V24-00400-29 Cable for Newport HT50 Ventilator: Class I Recall – Cable May Cause an Electrical Shortage That can Cause Ventilators to Shutdown Unexpectedly
AUDIENCE: Nursing, Risk Manager
ISSUE: The recalled cable may cause an electrical shortage that can cause Newport HT50 ventilators manufactured prior to 2007 to shutdown unexpectedly.
BACKGROUND: The V24-00400-20 cable is an accessory intended to transfer the alarm signal from a Newport HT50 ventilator to a nurse station. The affected cables were distributed between April 25, 2007 and July 6, 2011. A total of 328 cables were distributed within the US.
RECOMMENDATIONS: On August 23, 2011, Flight Medical sent an urgent Recall Notice to affected customers through its distributor, Newport Medical. Affected customers were advised to take the following actions:
- Stop using the alarm cable immediately
- Contact Newport Medical in order to receive an upgraded version of the cable free of charge.
- Customer inquiries related to this action should be addressed to Newport Medical’s Technical Service Group at 1-800-451-3111, extension 500.
- Affected cables should be disposed of according to local municipal guidelines.
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