The following document is a copy of a Press Release from Pulmonetic Systems, Inc. releated to the Class I Medical Device Recall of the Pulmonetic Systems LTV Series of Ventilators, Universal Cable Adaptor
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
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 CABLE ADAPTORS For Medical Ventilators
MINNEAPOLIS – Pulmonetic Systems, Inc., is voluntarily initiating a recall of 1,129 Universal Cable Adaptors (adaptors) used to power medical ventilators, distributed between November 2 and November 8, 2004 .
When attached to the ventilator’s power cord, the adaptor may not allow the ventilator to be powered up again if the ventilator’s internal battery has been depleted . Serious injury or death may result from this ventilator malfunction, unless an alternate means of ventilation is immediately available. In addition , some adaptors have not been attached securely to the ventilator’s power cord. The company has received two reports of ventilators failing to power up after internal battery discharge and three reports related to the adapter not being securely attached to the ventilator. No death or injury has been reported as a result of these recent failures.
The affected adaptors, labeled as either Part No. 17765-001 or PN 17820-001, were intended as a permanent field correction to the November 1, 2004, voluntary Class I Recall for malfunction of certain ventilators. These ventilators malfunction when the external DC power source is inadequate, causing failure of the ventilator to breathe for the patient, and which could result in permanent neurological failure or death. The recall initiated by Pulmonetic Systems on November 1, 2004, applies to LTV® Series Ventilators manufactured prior to September 2003 with serial numbers less than:
LTV 1000- S# A06500
LTV 900- S# B03500
LTV 950- S# C07000
LTV 800- S# D01400
and which do not have the ♪ (symbol of a musical note) symbol displayed on the ventilator rear panel label. (Upper left or lower right of rear panel label) Please check all ventilators in your inventory/control to ensure all affected devices are identified.
The company has notified customers who have received adaptors by certified mail on December 1, 2004 . They have been asked to remove the adaptors according to the instructions provided and return the adaptors to the company.
Interim Instructions when using affected ventilators without the adapter:
If you are using the ventilator on external battery or DC automobile power cable and the red VENT INOP alarm lights up and the alarm may sound, and the ventilator is not ventilating properly.
If you are using the ventilator on external battery or DC automobile power cable and the audible alarm may sound for 1 second duration every 3.5 seconds and the ventilator is not ventilating properly:
- Immediately unplug the external power source from the vent “pigtail”.
- If the ventilator does not immediately resume ventilation, “restart” the vent by pressing the On/Standby button.
As part of ventilator patient care, caregivers should always be prepared to provide alternate means of ventilation should any product malfunction occur.
The firm voluntarily took this action and promptly notified FDA. The permanent correction to the power switchover malfunction identified in the November 1, 2004 recall will be to replace the ventilator power board for each of the affected devices, according to the company. Customers will be receiving instructions shortly on how to return any affected devices for a power board replacement at a Pulmonetic Systems authorized Service Center .
Users with questions should contact their healthcare providers. Healthcare providers with questions should contact Pulmonetic Systems at 1-800-754-1914 extension 2.