Events

Safety Alert for Powerheart 9300A, 9300E, 9300P, 9390A, and 9390E; CardioVive 92532 and 92533; and CardioLife 9200G and 9231

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
    2012-01-31
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/press_20120201.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
    Press release
  • Reason
    Recall of cardiac science automated external defibrillators the department of health (dh) today (january 31) endorsed a local medical device supplier, pacific medical systems ltd's recall of a certain number of automated external defibrillators (aeds) made by a us manufacturer, cardiac science corporation, due to a possible failure in their delivery of defibrillation therapy. in fact, the recall is first initiated by cardiac science corporation in the us after it has detected through routine quality control that certain of its aeds made between july 1 and december 30, 2011 may not be able to perform. no report of rescue being impacted has been received anywhere in the world thus far. "according to cardiac science corporation, the affected models are powerheart 9300a, 9300e, 9300p, 9390a, and 9390e; cardiovive 92532 and 92533; and cardiolife 9200g and 9231," a dh spokesman quoted. "investigation by cardiac science corporation thus far reveals that the failure is likely due to a defect in a component of the circuit board which is amendable to corrective actions in the factory," the spokesman explained. pacific medical systems ltd reported that its sales record shows that they have imported some 135 involved devices into hong kong for supply to various users including dh. it will get in touch with affected customers to facilitate the return of the aeds for correction. in addition, the supplier has also set up a phone hotline at 2108 4005 for enquiries. "for the occasional customers who may have one of cardiac science corporation's aeds in hand and are uncertain about their status, they can visit the manufacturer's website at www.Cardiacscience.Com/aed210 to check by keying in the serial number marked at the back of individual devices," the spokesman elaborated. dh will be monitoring both the recall and in particular, the corrective action to be taken by pacific medical systems ltd. ends.

Device

Powerheart 9300A, 9300E, 9300P, 9390A, and 9390E; CardioVive 92532 and 92533; and CardioLife 9200...

Manufacturer

Cardiac Science Corporation