Events

Safety Alert for Aestiva/5 7900 SmartVent

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

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
    2012-06-28
  • Event Date Posted
    2012-06-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120628b.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: ge aestiva/5 7900 smartvent the united states food and drug administrations (fda) has issued a class i recall concerning aestiva/5 7900 smartvent (serial number amrp01031 amrp00966 amrp01030 amrp00968 amrp00967 amrp01033 amrp00970 amrp00969), manufactured by ge healthcare, llc. the manufacturer has recently become aware of a potential safety issue due to the interlock slide mechanism missing from the 3-vaporizer manifold of the aestiva 7900 anesthesia device. there is a potential for two vaporizers delivering agent at the same time. this could manifest as over delivery of a single agent if both vaporizers contain the same agent or as delivery of more than one agent. this may cause prolonged or persistent hypotension requiring medical intervention. to date, no injury has been reported to ge healthcare associated with this issue. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to fda websites http://www.Accessdata.Fda.Gov/scripts/enforcement/enforce_rpt-event- detail.Cfm?action=detail&id=61639&w=06272012 if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 28 june 2012.

Device

Aestiva/5 7900 SmartVent

Manufacturer

GE Healthcare