Hamilton Medical Archives - Medical Design Sourcing

Hamilton Medical’s ventilator recall is Class I

The FDA issued a notice labeling a recall of the Hamilton Medical Hamilton-C6 intensive care ventilator as Class I, the most serious kind.

Hamilton Medical initiated the recall for its ventilator on June 27, 2022. The recall is due to a hardware issue with the ventilator’s status indicator board. It covers 497 devices distributed between Aug. 31, 2017, and May 20, 2022. To date, Hamilton received 128 complaints related to the issue, with no deaths or injuries reported.

According to the FDA notice, customer complaints revealed that the Hamilton-C6 ventilator’s status indicator board may become loose, allowing liquid to enter (ingress) between the indicator board and the ventilator’s main board.

Water ingress may cause the ventilator to have a technical fault. This would revert the device to a safety ventilation mode or revert to an ambient state. In such a state, the patient breathes ambient room air with no assistance or support from the machine. Read more

Hamilton Medical warns on some ventilators

Hamilton Medical recently issued a field safety notice to warn on issues with some of its Hamilton-C6 ventilators.

Analysis of customer complaints revealed a hardware issue related to the status indicator board on the C6 ventilators. The board can become loose and may result in a loose contact to the mainboard and potential oxidation of the contact due to the ingress of water.

The defective contact results in a detected technical fault within a very short time, leading to an overflow of log entries forcing the ventilator into “safety ventilation” or “ambient state with panel connection lost” messages displayed.

According to the warning, dated June 10, 2022, Hamilton’s risk assessment concluded the issue to be “an almost impossible situation” but, for a passive patient, an ambient ventilation state may lead to a serious deterioration in the state of health. In case such a situation occurs, the ventilator displays …

Ultrasonically welded flow sensor critical to success of Hamilton Medical ventilator design

The body of the Hamilton Medical proximal flow sensor consists of two molded halves composed of medical-grade plastic. [Photo courtesy of Hamilton Medical] The disposable sensor monitors ventilation of critically ill patients with high precision.

Didier Perret, Emerson

Hamilton Medical (Bonaduz, Switzerland) produces intelligent ventilation solutions for intensive-care units and critical-care transports. To meet the exploding demand for ventilators during the COVID-19 pandemic, Hamilton Medical established a new ventilator production site in Reno, Nevada, with the support of a local team from General Motors.

In four months, the facility moved from bare floor to full production, delivering the first of thousands of Hamilton-T1 ventilators purchased under contract by the U.S. Department of Health and Human Services (DHHS) in September 2020.

Get the full story at our sister site, Medical Design & Outsourcing.

Report: U.S. ventilator stockpile is full

Philips Trilogy EVO portable ventilator (Image courtesy of Philips)

The U.S. Dept. of Health and Human Services (HHS) is reportedly terminating more ventilator contracts as the national stockpile is full.

The Hill reported today that HHS is throwing out some of the contracts that totaled $3 billion as the U.S. government sought to supply as many ventilators as possible during the first surge of the COVID-19 pandemic.

This news follows a recent announcement from Royal Philips (NYSE:PHG) that it would not be supplying the remaining 30,700 ventilators it was slated to manufacture by December to the Strategic National Stockpile, with HHS canceling the contract after the Amsterdam-based company delivered 12,300 total bundled ventilator configurations supplied to the stockpile through August, falling in line with the stipulations of the contract.

HHS has not divulged details on any terms of their can…