Archived - Update on Safety Information on the LTV Series Ventilators -Pulmonetic Systems, Inc.

Public Advisory

Health Canada Endorsed Important Safety Information on

LTV^® Series Ventilators

December 7, 2004

Subject: This important recall corrective action information update is provided in followup to the November 1, 2004 Pulmonetic Systems, Inc. class I recall notification previously sent to your facility.

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:

• LTV1000- S# A06500
• LTV 900- S# B03500
• LTV 950- S# C07000
• LTV 800- S# D01400

and which do not have the ♪ 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.

The identification, characterization, and management of medical device-related adverse incidents are dependent on the active participation of health care professionals in adverse incident reporting programmes. Any occurrences of adverse incidents in patients using LTV^® Series Ventilators should be reported to VitalAire Canada Inc. or Health Canada at the following addresses:

VitalAire Canada Inc.

2000 Argentia Rd.

Plaza 2, Suite 200

Mississauga, ON

L5N 1V8

Tel: 905-855-0414

Fax: 905-855-0742

Any suspected adverse reaction can also be reported to:

Health Products and Food Branch Inspectorate

HEALTH CANADA

Address Locator: 3002C

Ottawa, Ontario K1A 0K9

Tel: The Inspectorate Hotline 1-800-267-9675

For other inquiries: please refer to contact information:

Marketed Health Products Directorate

E-mail: mhpd_dpsc@hc-sc.gc.ca

Tel.: (613) 954-6522

Fax: (613) 952-7738

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada web site.