- Devices Recalled in the U.S.: 261 units were distributed to health care facilities in Virginia
AUDIENCE: Nursing, Risk Manager, Surgery, Emergency Medicine
ISSUE: Thornhill Research Inc. is recalling the MOVES ventilator system because excess glue on the battery connectors may prevent the battery from powering the device after the battery is stored. This issue may prevent the ventilator from providing patient breathing support and could cause patient injury or death. See the Recall Notice for further information, including manufacturing dates and distribution dates.
BACKGROUND: The MOVES Ventilator System is a portable emergency transport ventilator that provides breathing support for adults patients. The primary users of this device are medical doctors.
RECOMMENDATION: Thornhill Research Inc. sent a Recall Notification letter via email to affected customers on December 15, 2015. The letter provided instructions for performing a functionality test on these products. Customers were instructed to inform Thornhill of the test results. If the device is not functioning, Thornhill provided instructions for returning it to the firm for repair. Customers with questions should call Thornhill Research Inc. at: 416-597-1325.
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
- 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.
[01/27/2016 -Recall Notice - FDA]