Events

Field Safety Notices about G5/HAMILTON-S1 ventilators

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Hamilton Medical AG.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2016-03-07
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
  • Extra notes in the data
  • Reason
    Investigations have shown that after performing the suctioning maneuver, including disconnecting the patient, suctioning, and reconnecting the patient, the preset pattern of ventilation may not continue as expected. under certain conditions, a different ventilation mode than the operator- selected mode may be applied; this situation can occur independent from the selected patient group (neonate, pediatric, or adult). this situation may occur in the hamilton-g5 and hamilton-s1 if the ventilation mode changes during the pre-oxygenation phase. after the suctioning maneuver is finished and the patient is reconnected, the ventilation mode active before the pre-oxygenation phase is used. under these conditions, the ventilation mode displayed by the ventilator is not the same as the applied ventilation mode. .

Device

G5/HAMILTON-S1 ventilators
  • Model / Serial
    All HAMILTON-G5/HAMILTON-S1 ventilators with software versions v2.41, v2.42 and v2.50
  • Manufacturer
    Hamilton Medical AG

Manufacturer

Hamilton Medical AG