Newport Medical HT70 and HT70- Plus Ventilators…

Date

May 10, 2017

Risk class

Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)

Status

Terminated

Filed by

Newport Medical Instruments Inc

Product

Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the Newport HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs). The Newport HT70 is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. The Newport HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.

Reason

Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" HT70 Plus ventilators because they may shutdown spontaneously during normal operation without an accompanying alarm.

Distribution pattern

Worldwide Distribution - US (Nationwide) Internationally to Canada, Australia, Brazil, Japan, Korea, Mexico, Bahrain, Egypt, Greece Hungary, Ireland, Israel, Jordan, Kazakhstan, Lithuania, Mauritius Namibia, Norway, Pakistan, Poland, Qatar, Romania, Russian Federation South Africa, Spain, Turkey, United Arab Emirates, United Kingdom Algeria, Armenia, Austria, Bahrain, Belarus, Belgium, Botswana Bulgaria, Cyprus, Czech Republic, Denmark, Egypt, Finland, France Germany, Greece, Hungary, Iran, Ireland, Israel, Italy, Kenya, Lebanon Lithuania, Macedonia, Malawi, Malta, Mauritius, Mozambique, Netherlands Norway, Oman, Poland, Portugal, Qatar, Republic of Moldova, Romania Saudi Arabia, Serbia, Slovakia, Sudan, Sweden, Switzerland, Tunisia Turkey, Uganda, Ukraine, United Kingdom, Yemen, and Zimbabwe

Quantity

12,966

Codes and lots

All Newport Medical HT70 and HT70- Plus Ventilators

Recall started

March 30, 2017

Device type

Ventilator, Continuous, Facility Use

Root cause (FDA)

Software in the Use Environment

What the company told customers

Medtronic sent an Urgent Field Corrective Action Notice dated April 3, 2017, to all consignees via Federal Express or certified mail. The letter informed consignees of the remote potential for ventilator reset without accompanying alarm and the actions they should take. Customers were requested to acknowledge receipt and understanding of the Urgent Field Corrective Action Notice. Customers were also advised that a software service update will be available in May 2017 to address this issue. Medtronic issued a Press Release related to this voluntary field action on April 5, 2017. Consignees with questions were advised to contact the Technical Support Department immediately at 800-255-6774. For questions regarding this recall call 203-492-5415.

Recall number

Z-1874-2017

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1874-2017. The agency record governs; check it and the company before acting.