Events

Safety Alert for Pressure Display Box (66000, 64000, 63000, 60000) with Pressure Display Set (Models 61000, 61006, 62000, 62006)

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

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
    2011-11-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111128.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
    Field safety notice: medtronic pressure display box (66000, 64000, 63000, 60000) with pressure display set (models 61000, 61006, 62000, 62006) medical device manufacturer, medtronic inc. has issued a field safety notice concerning pressure display box, model 66000, with disposable pressure display set (models 61000, 61006, 62000, 62006). the notice intended to inform users about the clarification related to the directions of use (dfu) provided with the product according to medtronic, the display reading of the press display box may vary more than +/- 5mmhg from actual line pressure during use in the -40 to -100mmhg range, which is different from the figure stated in the dfu. previous pressure display boxes which may still be in use (models 60000, 63000 and 64000) 64000), do not include accuracy information beyond -50 mmhg for negative pressure in their dfu, but are expected to perform similarly to the model 66000. besides, medtronic clarified that the intended use of the disposables is only for cardiopulmonary bypass surgery (procedures up to 6 hours). use beyond 6 hours may result in air leakage in the system resulting in an inaccurate pressure reading. medtronic intends to update the directions for use (dfu) provided with the products to address the abovementioned issues. according to the local supplier, the device has been distributed in hong kong, and they are in the process of notifying the affected customers. if you are in possession of the affected products, please contact your supplier for necessary actions.

Device

Pressure Display Box (66000, 64000, 63000, 60000) with Pressure Display Set (Models 61000, 61006,...
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic Pressure Display Box (66000, 64000, 63000, 60000) with Pressure Display Set (Models 61000, 61006, 62000, 62006)
  • Manufacturer
    Medtronic Inc.

Manufacturer

Medtronic Inc.
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH