Events

Safety Alert for Powerheart Automated External Defibrillator (AED) Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, 92533, NK 9200G, 9231, and Responder 2019198, 2023440

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

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
    2011-10-21
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111022.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
    Fda field safety notice: cardiac science corporation powerheart automated external defibrillator (aed) powerheart 9300a, 9300c, 9300d, 9300e, 9300p, 9390a, 9390e, cardiovive 92532, 92533, nk 9200g, 9231, and responder 2019198, 2023440. the us food and drug administration (fda) issued a class ii recall related to powerheart automated external defibrillator (aed) powerheart 9300a, 9300c, 9300d, 9300e, 9300p, 9390a, 9390e, cardiovive 92532, 92533, nk 9200g, 9231, and responder 2019198, 2023440 manufactured by cardiac science corporation (csc). the aeds may enter into a "service required" state due to two errors, "0x48" and "0x99". according to the csc, the status indicator on the aed will turn red when the errors occur, which means immediate check-up is required. csc reminds owners/operators of the powerheart aed devices to verify the "rescue readiness" of their equipment and follow maintenance procedures as specified in operation and maintenance guides provided with every aed. if, at any time, the status indicator turns red, the user must not use the device and should contact the local responsible person for service as soon as possible. according to the local supplier, pacific medical systems, the affected devices have been distributed in hong kong. pacific medical systems supplemented that all affected users will be informed accordingly. for details, please refer to the following link: http://www.Fda.Gov/safety/recalls/enforcementreports/ucm275510.Htm if you are in possession of the affected product, please contact your supplier or pacific medical systems for necessary actions.

Device

Powerheart Automated External Defibrillator (AED) Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Cardiac Science Corporation Powerheart Automated External Defibrillator (AED) Powerheart 9300A, 9300C, 9300D, 9300E, 9300P, 9390A, 9390E, CardioVive 92532, 92533, NK 9200G, 9231, and Responder 2019198, 2023440
  • Manufacturer
    Cardiac Science Corporation

Manufacturer

Cardiac Science Corporation