Medtronic (MDT: 41.79 +0.12 +0.29%, vol: 6,694,751, 52wk: 24.06 - 46.66) the manufacturer of the Physio-Control Lifepak Defibrillators has signed a Consent Decree of Permanent Injunction with the FDA.

The Consent Decree is related to the Physio-Control’s AEDs (Automatic External Defibrillators). The Decree prohibits the manufacture, distribution, and export of specific model AEDs from the Physio-Control manufacturing plant in Redmond, Washington. The decree will be active and in-place until such a time that Medtronics and Physio-Control are found to be in compliance the FDA’s “current Good manufacturing Practices” (cGMP).

The AEDs subject to the Decree include:

  • LIFEPAK 12
  • LIFEPAK 20
  • LIFEPAK 500
  • LIFEPAK 1000
  • LIFEPAK CR PLUS
  • LIFEPAK EXPRESS
  • and their components and accessories, including the LIFENET Systems.

    • The Decree which was filed with the US Supreme Court for the Western District of Washington is subject to court approval.

    Physio-Control has released a statement in which they have stated that:

    “Under Paragraph 5 of the agreement, Physio-Control is permitted to manufacture and ship a limited selection of product to meet the most critical needs of emergency response customers. As you may recall, in August 2007, Physio-Control voluntarily began this process in the United States. However, under the terms of the agreement, these limited exceptions will now apply worldwide. This provision will ensure that emergency care providers can continue to support the needs of public health and safety, while allowing Physio-Control to continue progress on the improvement of its quality system processes.

    We wanted to share this news with you as soon as possible, however, no action is required on your part. Be assured that Physio-Control products can and should continue to be used for patient care. This agreement does not reflect any specific product reliability or safety concerns with LIFEPAK products. Physio-Control will continue to provide service, disposables and accessories to our customers. We will also continue to work with our customers to support currently implemented AED Programs.”

    How are you dealing with the injunction? 

    What steps are you taking to ensure that your facility can get the equipment and accessories it requires to continue operations?

    Via Biomedtalk Listserv

    FDA Press Release - Medtronics Consent Decree

    Physio-Control Letter to Customers and Partners

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