Class 1 Recall: Pulmonetic Systems LTV Series of Ventilators, Universal Cable Adaptor

[Brian, ASN, RN]

FDA MedWatch - Class 1 Recall: Pulmonetic Systems LTV Series of Ventilators, Universal Cable Adaptor

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

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