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U.S. Department of Health and Human Services

Medical Devices

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Pulmonetic Systems LTV Series of Ventilators, Universal Cable Adaptor - Interim Instructions

The following document is a copy of a Interim Instructions 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.

December 7, 2004

Certified Mail

This Important Recall Corrective Action Information Update is provided in follow-up to the November 1, 2004 Pulmonetic Systems, Inc. Class I Recall Notification previously sent to your facility.

Dear Valued Customer:

We sent a Recall Notification to you on November 1, 2004 regarding the possibility of a power switchover malfunction in certain LTV Series Ventilators. This recall notification discussed the provision of a Universal Cable Adapter (UCA) as a permanent field correction for all affected units.

Due to some reported problems with this Universal Cable Adaptor (UCA), we have discontinued shipment of these adapters and have recalled the limited number of adapters distributed. The permanent resolution for the power switchover malfunction will now be to replace the power board within all LTV ventilators affected. We plan to complete the power board upgrades within 12 months for domestic devices and 18 months for international devices. We will contact you very shortly to make arrangements to service these units and will make every effort to minimize disruption for users.

To reiterate, the November 1, 2004 Recall Notification 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). Until affected devices in your inventory are updated, ventilator users should follow the Interim Instructions listed below and described in the November 1, 2004 Recall Notification.

Interim Instructions:

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.

or

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:

  1. Immediately unplug the external power source from the vent “pigtail”.
  2. 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.

If you have any additional questions please do not hesitate to contact our Customer Care department at 800-754-1914, ext. 2 or 763-398-8500.