2 Medtronic ventilators can stop working without notice
Two models of Medtronic ventilators used in pediatric and adult care can reset during
operation and stop working, according to a safety notice from the Food and Drug Administration
The prescription Newport HT70 and HT70 Plus ventilators are used to support breathing
in clinical settings and in the home. If the ventilators reset spontaneously while
in operation, they enter standby mode without an accompanying alarm and will not resume
ventilation without intervention. If this occurs, health care professionals and caregivers
must transfer the patient to another ventilator. Families also should contact their
A software update is expected to become available in May. Meanwhile, the firm said
the HT70 series ventilators still can be used but cautions caregivers to provide constant
monitoring of the patient’s condition. In addition, they should have an alternate
power source and means of ventilation available and use appropriate monitors to ensure
sufficient oxygenation and ventilation (such as a pulse oximeter and/or a capnograph)
when these ventilators are in use.
Since 2012, Medtronic has received 12 reports of resets without an accompanying alarm,
and 11 patients required a ventilator transfer. One incident did not involve a patient.
For assistance finding alternative ventilation devices, call Medtronic at 800-255-6774.
Health care professionals and patients are asked to report any adverse events to the
FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.fda.gov/MedWatch/report or by calling 800-332-1088.