Dive Brief:
- Hamilton Medical has recalled ventilators because the devices may fail to restart, the Food and Drug Administration said Thursday.
- Ventilators that fail to restart may cause low blood oxygen, slow heart rate and other negative health outcomes. The FDA said there have been reports of one injury and one death associated with the issue.
- The recall is a correction and does not require products to be removed from the market. Hamilton is asking users to check if their devices use the affected version of the software and update their systems.
Dive Insight:
Healthcare providers use the recalled Hamilton-C6 device to provide children and adults with mechanical ventilation or breathing support. The company markets the devices as ICU ventilators, but the FDA said they are also used in other healthcare settings including long-term acute care and to transfer ventilated patients within hospitals.
Hamilton wrote to customers in May after identifying a “software anomaly.” Hamilton-C6 devices with three versions of the software “may fail to restart ventilation if it enters sensor fail mode after open suction is performed and the patient is reconnected,” the FDA said.
There are four ways to re-initiate ventilation when a device suffers from the fault, Hamilton said. The options open to healthcare professionals include selecting new settings or switching the ventilator off and on. Hamilton said the fault may result in a prolonged problem until the user understands and resolves the issue.
The latest software, version 1.2.3, includes a fix for the problem. Hamilton is advising users that still have one of the older versions of the software to attach its letter about the fault to the affected device’s operator’s manual.
The FDA categorized the recall, which could affect 68 devices, as a Class I event in June. Hamilton-C6 was the subject of another Class I recall in 2022. The earlier recall notice described the potential for the ventilator status indicator board to become loose and allow water into the system, which could affect breathing support.