Events

Safety Alert for FRED easy & FRED easy Life Defibrillators

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

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
    2012-05-22
  • Event Date Posted
    2012-05-22
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120522b.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: schiller medical fred easy & fred easy life defibrillators the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning fred easy & fred easy life defibrillators manufactured by schiller medical. according to schiller medical, two problems have been identified regarding “transistor charge error” message and quality of the electrodes. transistor charge error: on some devices, during use, or during a self test, a message “transistor charge error” has occurred. in the analysed cases (field and laboratory results), all occurrences were “false positive”, the devices were not affected by a failure. as a consequence, the device is unavailable until it is restarted. the occurrence of the failure is estimated to 0.2%. the corrective action consists in a software update, which prevents the occurrence of the “false positive”. electrodes: a decline in the quality, before expiry date, has been observed for some schiller electrodes manufactured by nessler (p/n 0-21-0000, 0-21-0003, 0-21-0020, 0-21-0021, 0-21-0013, 0-21-0024, 2.155056, 2.155057, w1410241, w1404262). the consequences were a decrease of survival chances for some patients, due to the lack of heart rhythm analysis. all schiller electrodes which are still on the market, with a valid expiry date and manufactured by nessler, will be exchanged by new schiller electrodes manufactured by leonhard lang. according to the local supplier, the affected products have been distributed in hong kong. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted 22 may 2012.

Device

FRED easy & FRED easy Life Defibrillators
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Schiller Medical FRED easy & FRED easy Life Defibrillators
  • Manufacturer
    Nessler

Manufacturer

Nessler