Hamilton Medical, Inc., HAMILTON-T1 Ventilators with Software Versions 1.1.2 and Lower
AUDIENCE: Anesthesiology, Risk Managers
ISSUE: During ventilation of small pediatric patients with high airway resistance and low lung function, there may be unexpected high internal oxygen consumption by HAMILTON-T1 ventilators with software versions 1.1.2 and lower. This may cause miscalculation of the required oxygen needed for long time applications with limited oxygen supply. The HAMILTON-T1 oxygen capacity must be calculated using a larger margin than originally expected.
BACKGROUND: The HAMILTON-T1 ventilator provides continuous or intermittent breathing support to adults and pediatric patients. HAMILTON-T1 ventilators with software versions 1.1.2 and lower; part numbers 161005 and 161006 are affected. This device was manufactured and distributed from February, 2012 through December, 2012.
RECOMMENDATION: On January 11, 2013, Hamilton Medical mailed a letter notifying their customers of the problem and informed them that the firm is working on a software version with reduced oxygen consumption. The letter included a "Medical Device Safety Alert and Corrective Action" document. The firm asked their customers to review this document for details regarding the root cause and corrective action with the current 1.1.2 or lower software.
Customers will be notified upon completion of the new software. Arrangements will be made to provide a loaner unit while the customer’s T1 ventilator is returned to the firm’s Reno Service Department for the software upgrade. The firm also directed their customers to update their T1 Operator Manuals with an included Oxygen Consumption formula page which provides revised information for calculating oxygen capacity.
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
[02/07/2013 - Recall Notice - FDA]