Medtronic Announces Worldwide Voluntary Field Corrective Action For Newport(TM) HT70 and Newport(TM) HT70 Plus Ventilators
(Thomson Reuters ONE) -
DUBLIN - April 5, 2017 - Medtronic (NYSE: MDT) is notifying customers worldwide
of a voluntary field corrective action for all its Newport HT70 and Newport HT70
Plus ventilators manufactured since 2010. The voluntary field corrective action
is being conducted following reports that the ventilator may reset spontaneously
during normal operation, without an accompanying alarm. The reported incidence
of this condition is approximately one (1) reset in every seven million hours of
ventilation. Following the reset, the ventilator enters standby mode and will
not resume ventilation without intervention. In the event of the rare occurrence
of a reset, healthcare professionals and/or caregivers are required to transfer
the patient to another ventilator.
A Newport HT70 ventilator is used to support a patient's breathing. This
prescription device is operated by trained healthcare professionals in a
clinical setting and in the home for infant, pediatric and adult patients.
Since Aug. 2012, and of the more than 14,000 ventilators in use, Medtronic has
received 12 reports of the reset without an accompanying alarm. Of these 12
reports, 11 patients required ventilator transfer and one (1) incident did not
involve a patient. No patient injury or impairment has been reported.
Medtronic has established the root cause of this alarm failure and will provide
a software service update to resolve the issue as soon as the correction can be
implemented. We expect the service update to be available in May.
Medtronic is advising that you may continue to use your Newport HT70 series
ventilators in accordance with institutional policies and as described below.
Actions you should take:
* Ensure patients on the Newport HT70 and HT70 Plus ventilators are
appropriately monitored by trained caregivers as described in the Operator's
Manual. The descriptions include:
* A patient connected to a ventilator requires the constant attention of
trained caregivers to the patient's condition.
* Always have an alternate power source and means of ventilation available
when the ventilator is in use in case of a mechanical or system problem.
* Always use appropriate monitors to ensure sufficient oxygenation and
ventilation (such as a pulse oximeter and/or a capnograph) when the
Newport HT70 or HT70 Plus ventilators are in use on a patient.
* If able, use the appropriate remote alarm/nurse call cable (CBL3223 or
10104494) to project ventilator alarm states outside the patient room.
This alarm will annunciate even with an unexpected reset. Consult the
Operator's Manual or call Technical Service for further information on
this accessory.
* If, at any time, the patient is not responding to ventilation
appropriately, the patient should be taken off the ventilator
immediately and connected to an alternate method of ventilation. Contact
your health care provider or physician immediately.
* Immediately notify all care environments in which the Newport HT70 and HT70
Plus ventilators are used about this notification.
* If your facility has distributed Newport HT70 or HT70 Plus ventilators to
other persons or facilities, please promptly forward this announcement to
those recipients.
* Work with Medtronic Technical Support Department if you require assistance
finding alternative ventilation devices.
Medtronic has contacted the FDA and other regulatory bodies to share information
related to this issue. We will continue working directly with government
authorities and our customers on this voluntary field corrective action.
If you are aware of any incidents related to these issues or if you have any
questions, please contact our Technical Support Department immediately at
+1-800-255-6774 to provide information regarding those events so regulatory
reporting obligations can be fulfilled. Adverse reactions or quality problems
experienced with the use of this product may be reported to the FDA's MedWatch
Adverse Event Reporting program online, by regular mail, or by fax.
* Online: Complete and submit the report to www.fda.gov/medwatch/report.htm
* Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call
+1-800-332-1088 to request a reporting form, then complete and return to the
address on the pre-addressed form, or submit by fax to +1-800-FDA-0178
or
* Email Medtronic Post Market Vigilance at: HQTSWEB(at)COVIDIEN.COM
* Call Medtronic Post Market Vigilance at: +1-800-255-6774 option 4, then
option 2.
List of countries with Newport HT70 and Newport HT70 Plus ventilators
Algeria, Argentina, Australia, Bahrain, Bangladesh, Belgium, Bolivia, Brazil,
Brunei, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia,
Cyprus, Dominican Republic, Ecuador, Egypt, Greece, Hong Kong, Hungary, India,
Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Lebanon,
Lithuania, Malawi, Malaysia, Mauritius, Myanmar, Mexico, Namibia, Nepal,
Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines,
Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Senegal,
Serbia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Switzerland,
Taiwan, Thailand, Tunisia, Turkey, United States, United Arab Emirates, United
Kingdom, and Vietnam.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among
the world's largest medical technology, services and solutions companies -
alleviating pain, restoring health and extending life for millions of people
around the world. Medtronic employs more than 88,000 people worldwide, serving
physicians, hospitals and patients in approximately 160 countries. The company
is focused on collaborating with stakeholders around the world to take
healthcare Further, Together.
Any forward-looking statements are subject to risks and uncertainties such as
those described in Medtronic's periodic reports on file with the Securities and
Exchange Commission. Actual results may differ materially from anticipated
results.
-end-
Contacts:
John Jordan
Public Relations
+1-508-452-4891
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Medtronic plc via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 05.04.2017 - 14:00 Uhr
Sprache: Deutsch
News-ID 534661
Anzahl Zeichen: 7447
contact information:
Town:
Dublin
Kategorie:
Business News
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