Recall Z-2020-2024 ยท CBK Ventilator, Continuous, Facility Use
Hamilton Medical AG
Ventilator HAMILTON-C6, PN: 160021
| Date | Jun 18, 2024 (initiated May 15, 2024) |
| Status | Open, Classified |
| Reason | Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnected, which may cause hypoxia, if this sequence occurs: 1)User presses O2 enrichment, 2)User disconnects endotracheal tube for open suctioning, 3)Sensor error initiated, sensor fail mode occurs, 4)Patient is re-connected with sensor fail mode active, 5) Ventilation is not re-initiated by the ventilator. |
| Root cause | Packaging change control |
| Action | On 5/24/24, correction notices were emailed to customers and distributors and they were asked to do the following: If ventilation is not re-initiated due to this issue, there are 4 ways to reinitiate ventilation: 1) Select and confirm a control setting (even without a change of the value), or 2) Select and confirm a new ventilation mode, or 3)Switch the ventilator to standby mode and restart ventilation from standby mode, or 4) Switch the ventilator off and switch it on again If the user is not able to manually re-initiate ventilation in due time as per one of the 4 ways described above, th |
| Quantity | 68 |
| Distribution | US Nationwide distribution in the states of GA, KY, FL, IN, NV, MI, VA, OR, TX, SC, CA, PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201658 | Hamilton-C6 Hamilton Medical AG, Dec 11, 2020 |