Recall Z-0741-2013 ยท CBK Ventilator, Continuous, Facility Use
Hamilton Medical Inc
HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics
| Date | Jan 31, 2013 (initiated Dec 19, 2012) |
| Status | Terminated |
| Reason | Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a Hamilton T1 ventilator with software versions 1.1.2 and lower must be calculated using a larger margin than originally expected. |
| Root cause | Software design |
| Action | Hamilton sent a Field Safety alert letter dated January 11, 2013 to all customers. The letter identified the affected product, explained the potential problem and a included Medical Device Safety Alert and Corrective Action document. Hamilton is working on a new software version for this issue. Customers are asked to update their operator manual with the update oxygen consumption formula page which provided revised information for calculating oxygen capacity. When the new software is available, Hamilton will provide loaner devices to each location while their unit is being upgraded. Quest |
| Quantity | 97 total ventilators; 69 of part number 161005 and 28 of part number 161006 |
| Distribution | US Nationwide Distribution including the country of Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120670 | HAMILTON-T1 Hamilton Medical AG, Apr 3, 2012 |