Events

Safety Alert for D-Fend/D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors

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
    2015-04-30
  • Event Date Posted
    2015-04-30
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150430.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 healthcare d-fend/d-fend+ water traps used with compact airway modules e/m-c(ai)o(v)(x) and cardiocap/5 monitors australian therapeutic goods administration (tga), has issued a medical device safety alert concerning d-fend/d-fend+ water traps used with compact airway modules e/m-c(ai)o(v)(x) and cardiocap/5 monitors, manufactured by ge healthcare. the affected devices are identified as follow:- d-fend: product number: 876446-hel; lot numbers: j9964985, j10201698, j10258248, j10284871, j10284872, j10344108 d-fend+ : product number: 881319-hel ; lot numbers:: j9906966, j9965152, j10258251, j10300071 the manufacturer has recently become aware of a potential safety issue due to loss of gas monitoring associated with occlusion of specific d-fend/d-fend+ water traps used with compact airway modules e/m-c(ai)o(v)(x) and cardiocap/5 monitors. occlusion of specific lots of d-fend/d-fend+ water traps could occur immediately after replacement. this water trap occlusion could cause a loss of respiratory airway gas monitoring. when this issue is detected the connected monitoring device will issue an audio alarm and display “low gas sample flow”, “replace water trap” or “sampling line blocked” warning messages. unattended or prolonged warnings could lead to an adverse clinical situation if the co2 value would rapidly change in certain clinical conditions affected users are advised to collect and dispose of the affected water traps. the manufacturer will replace all affected products. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2015-rn-00366-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 april 2015.

Device

D-Fend/D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 moni...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: GE Healthcare D-Fend/D-Fend+ water traps used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare