Events

Safety Alert for Physio-Control, LIFEPAK 20e Defibrillator/Monitor

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

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
    2018-01-09
  • Event Date Posted
    2017-01-09
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180109b.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: physio-control, lifepak 20e defibrillator/monitor medical device manufacturer, physio-control, has issued a medical device safety alert concerning its lifepak 20e defibrillator/monitor [model/catalog numbers: 70507-xxxxxx, 99507-xxxxxx; lot number multiple]. the manufacturer is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. the symptoms of these failures may include unexpected power on and power off, device lock-up, or a failure to power on or off. according to the manufacturer, the failures are the result of the manufacturing process residue located beneath a component mounted on the power printed circuit board assembly (pcba). this has the potential to result in a failure to deliver therapy to the patient and serious injury or death. the manufacturer has not received any adverse events reported as a result of this issue. the manufacturer will contact potential affected users to arrange for a device correction included the replacement of the power pcba. the customers are requested to follow the recommended daily operator’s checklist steps in accordance with lifepak 20e defibrillator/monitor operating instructions – section 7 – maintaining the equipment. if the users experience any of the symptoms described above, contact the manufacturer immediately to arrange servicing to your device. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 09 january 2017.

Device

Physio-Control, LIFEPAK 20e Defibrillator/Monitor
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Physio-Control, LIFEPAK 20e Defibrillator/Monitor
  • Manufacturer
    Physio-Control

Manufacturer

Physio-Control
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    DH