The following document is a copy of a Press Release from Pulmonetic Systems, Inc. related to the Class I Medical Device Recall of the Pulmonetic Systems LTV Series of Ventilators.
FOR IMMEDIATE RELEASE
Monday, September 27, 2004
FOR: Pulmonetic Systems, Inc.
17400 Medina Road, Suite 100
Minneapolis, MN 55447
CONTACT: Dave Neuger
Neuger Communications Group
888.761.3400 (toll free)
PULMONETIC SYSTEMS, INC. ISSUES NATIONWIDE RECALL OF CERTAIN LTV VENTILATORS
MINNEAPOLIS – Pulmonetic Systems, Inc., Minneapolis, Minnesota, is voluntarily initiating a recall of approximately 10,000 of its portable ventilators intended for mechanical ventilation of adults and children in homecare, hospitals and other institutions. The ventilators being recalled were manufactured before September 1, 2003.
The ventilators malfunction when switching to the internal battery when the external power source is inadequate. This problem causes failure of the ventilator to breathe for the patient, which could result in permanent neurologic injury or death.
The company has received approximately 30 reports of this malfunction in which injury was averted by prompt caregiver action. The company has received one report of a patient death possibly associated with this situation which remains under investigation.
A Safety Alert, accompanied by a Caregiver Information Sheet, was sent out by the company as an interim solution on September 7, 2004, to inform customers and users of this potential malfunction. These publications describe the malfunction, the alarms that should occur, and give detailed instructions to users on how to immediately correct the malfunction and resume appropriate ventilation. If instructions in the Safety Alert are properly followed, the unit will usually continue to provide ventilation.
There is the remote possibility that when switching to internal battery operation, the ventilator may not operate after disconnecting from an inadequate external power supply, if the internal battery is not properly charged. External DC power sources include three and nine hour lead-acid batteries as well as automobile batteries powering the ventilator through a cigarette lighter adapter. As identified in the Safety Alert, and as part of ventilator patient care, caregivers should always be prepared to provide alternate means of ventilation should any product malfunction occur.
The company expects to provide a permanent solution for all affected devices that can be easily installed by the caregiver beginning within the next 4-6 weeks. Meanwhile, users and caregivers need to read the Caregiver Information Sheet to understand how to react in the event this malfunction should occur.
The recall includes all LTV series ventilators manufactured before September 1, 2003 unless they are specifically marked on the back panel label of the ventilator with a symbol of a music note in the upper left or lower right hand corners. The following models and serial numbers may be affected:
LTV 1000 Serial Numbers below A06500
LTV 950 Serial Numbers below C07000
LTV 900 Serial Numbers below B03500
LTV 800 Serial Numbers below D01400
The firm voluntarily took this action and the FDA has been apprised. This action has been classified by the Food and Drug Administration (FDA) as a Class I Recall. The FDA defines a Class I recall as a situation in which there is a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.
Pulmonetic Systems has notified affected device owners by certified mail. Users with affected devices who have not received a copy of the Safety Alert or the Caregiver Information Sheet should contact their healthcare provider, or Pulmonetic Systems to obtain a copy. Users with questions should contact their healthcare providers. Healthcare providers with any questions should contact the firm at 1-800-754-1914 extension 2.