Events

Safety Alert for Hamilton-C2 (PN 160001) and Hamilton-C3 (PN 160005) Ventilator Unit

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Hamilton Medical AG.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2017-09-05
  • Event Date Posted
    2017-09-05
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170905.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: hamilton medical ag hamilton-c2 (pn 160001) and hamilton-c3 (pn 160005) ventilator unit the medicines and healthcare products regulatory agency (mhra) of the united kingdom (uk) has issued a medical device safety alert concerning hamilton-c2 (pn 160001) and hamilton-c3 (pn 160005) ventilator unit, manufactured by hamilton medical ag. the analysis of a customer complaint has identified an issue relating to the battery charge of the hamilton-c2/c3 batteries after a usage of two and a half years. the battery fuel gauge may indicate a higher battery charge as to what is available. the technical failure 444001"low battery" high priority alarms are triggered, alerting the operator both acoustically and visually before entering ambient mode. according to the manufacturer, when batteries are depleted, the operator is alerted by high priority alarms and if the ventilator is not immediately connected to an ac power outlet, the ventilator will switch into ambient mode. the alarm is triggered in every case to alert medical staff. the affected users are instructed to take the following actions:- the operator should make themselves familiar with the batteries' manufacturing date and react in time if battery is more than two years old. any battery with a manufacturing date to two years prior to the current date should be replaced. if the battery is less than two years old, return battery to slot, pushing until clip clicks into place, locking in the battery. use a screwdriver to lock metal clip back into place over battery. close battery door. for details, please refer to the mhra website: https://www.Gov.Uk/drug-device-alerts/field-safety-notice-29-august-to-1-september-2017 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 5 september 2017.

Device

Hamilton-C2 (PN 160001) and Hamilton-C3 (PN 160005) Ventilator Unit
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Hamilton Medical AG Hamilton-C2 (PN 160001) and Hamilton-C3 (PN 160005) Ventilator Unit
  • Manufacturer
    Hamilton Medical AG

Manufacturer

Hamilton Medical AG