Hamilton’s Ventilator Recall Amid Shutdowns

In recent times, the significance of ventilators has been magnified by the demands of the COVID-19 pandemic. However, a persistent issue of malfunctioning devices has posed an ongoing challenge for the FDA. This year alone, the agency has dealt with a series of Class I recalls involving breathing support machines from various medtech manufacturers. Among the latest Class I recalls is one involving Hamilton Medical, as the company grapples with unexpected ventilator shutdowns.

Hamilton’s recall, which began during the summer, has impacted over 21,000 ventilators, spanning models C1, C2, C3, and T1. These devices play a vital role in providing breathing assistance to patients of all age groups, either partially or entirely. The severity of the situation is underscored by the FDA’s Class I rating, which signals a significant risk of serious injuries or even fatalities linked to the malfunctioning ventilators.

The recall encompasses devices distributed over more than a decade, from December 2010 to May of the current year. Affected devices were equipped with specific versions of Hamilton’s software and included the “neonatal option.”

The catalyst for the recall was a series of reports received by Hamilton, revealing that software glitches were causing some ventilators to unexpectedly switch to an “Ambient State.” This transition triggered an audible alarm and displayed a “technical fault” message on the device screens. The issue primarily affected ventilators that had been in operation for over three months without a system restart.

The consequences of a ventilator shutdown are grave, as medical professionals must rapidly seek alternatives or resort to manual resuscitation devices to sustain a patient’s breathing. The FDA underscores that inadequate breathing support could lead to severe repercussions, including fatalities.

Despite 80 complaints related to the software malfunctions, Hamilton has not reported any injuries or deaths linked to the issue.

In response to the recall, Hamilton promptly notified healthcare providers about the necessary actions in case of an unexpected shutdown. Providers were advised to completely power down the ventilator to exit the “Ambient State” and immediately transition to an alternate respiratory support system. Subsequently, the affected ventilators require servicing before they can be returned to normal operation. Detailed instructions were provided by the company and included in the FDA’s recall database.

For the C1 and T1 models, upgrading the software to version 3.0.0 or higher can prevent shutdown issues.

To mitigate potential future malfunctions across all the recalled models, Hamilton recommended that healthcare providers periodically restart the ventilators. This precaution is most effective when performed during the exchange of breathing circuits, a routine procedure conducted approximately every four weeks. The company emphasized that merely switching to standby mode is insufficient to address the concern.