Events

Safety Alert for IW900-series Infant Warmers

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Fisher & Paykel 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
    2014-11-06
  • Event Date Posted
    2014-11-06
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141106a.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: fisher & paykel healthcare iw900-series infant warmers it has come to our attention that medical device manufacturer, fisher & paykel healthcare, has initiated a field safety corrective action concerning some of its iw900-series infant warmers. there were two confirmed reports of breakage of the nut that secures the heater head in place. breakage of the nut can cause the heater head to become partially detached and swing towards the bassinet. the heater head did not contact the patient in either case, however there is the potential that a heater head could contact a patient situated on the bassinet and cause a serious injury. users should check whether they have the affected infant warmers and the spare parts. the manufacturer is supplying replacement pivot securing nuts to all affected customers. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 november 2014.

Device

IW900-series Infant Warmers
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Fisher & Paykel Healthcare IW900-series Infant Warmers
  • Manufacturer
    Fisher & Paykel Healthcare

Manufacturer

Fisher & Paykel Healthcare