December 10, 2004
FDA ALERT
The Universal Cable Adaptor intended to
correct an earlier Class I recall of LTV series ventilators,
Z-1485-04, is not functioning as intended. The adaptor
may not allow the ventilator to be powered up again if
the ventilator's internal battery has been depleted or
may not be securely attached to the pigtail connector
on the ventilator. Customers have been asked by the firm
to remove the adaptors according to instructions provided
to them and return the adaptors to the company. Pulmonetic
Systems' permanent resolution of the ventilator's power
switchover malfunction will be to replace the power circuit
board for all affected LTV Series Ventilators.
Read the MedWatch 2004 safety summary, including a link
to the FDA recall notice, at:
http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#Cable
October 1, 2004
FDA and Pulmonetic Systems, Inc. notified
healthcare professionals of a Class I recall of the LTV
series of ventilators, models 1000, 950, 900 and 800,
designed to automatically switch to internal battery
operation, allowing uninterrupted ventilation, when an
external power source is removed or is no longer adequate
to power the ventilator. The ventilators malfunction
when switching to the internal battery, causing failure
of the ventilator to breathe for the patient.
Read the MedWatch 2004 safety summary, including a link
to the FDA recall notice, at:
http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm#Pulmonetic
Approximately 10,300 of these devices are in domestic
and international distribution. This series of LTV ventilators
is used to provide continuous or intermittent breathing
support for adult or pediatric patients weighing at least
11 lbs. who require mechanical ventilation. The devices
are designed to automatically switch to internal battery
operation, allowing uninterrupted ventilation, when an
external power source is removed or is no longer adequate
to power the ventilator.