Archived – Safety Information on the LTV Series Ventilators – Pulmonetic Systems – For the Public

PUBLIC ADVISORY
Health Canada Endorsed Important Safety Information on LTV^® Series Ventilator

September 7, 2004

Subject: : Important information on the safe and proper operation of the LTV^® Series Ventilators With Lead Acid Batteries, Universal Power Supply or Automobile Cigarette Lighter/Accessory Power Outlet

To: LTV^® Series Ventilator Purchasers/Owners

From: Angela King, Clinical Director

This Safety Alert applies only to LTV^® Series Ventilators manufactured prior to September 2003 with serial numbers less than:

• LTV 1000- S# A06500
• LTV 950- S# C07000
• LTV 900- S# B03500
• 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)

A list of affected devices in your inventory, according to our records, is attached for your review.

Units manufactured after September 1, 2003 are not affected by this safety alert.

SITUATION

The LTV^® Series of Ventilators (Models LTV^®; 1000, 950, 900 and 800) are designed to operate from an external AC adaptor, internal DC battery power, or external DC battery/automobile power source. The devices are designed to automatically switch to internal battery operation, allowing uninterrupted ventilation, when an external power source is removed or is no longer adequate to power the ventilator.

We have received and documented in our quality system approximately 30 reports (0.3% of devices) where the ventilator has not switched to internal battery operation when the external DC power source has become inadequate to supply stable power to the ventilator. In these instances, the ventilator does not continue to provide ventilation to the patient. The ventilator does alarm, alerting the caregiver when this situation occurs. If device user instructions are not properly followed, this failure mode could result in a death or serious injury. Since this condition can be difficult for ventilator user's to describe, we believe there may be other additional instances of this occurrence.

Appropriate management and use of external power sources is also very important since older batteries and those that experience a greater number of charge/recharge cycles may have increased risk of experiencing the situation to which this alert pertains. Please refer to the attached September 23, 2002 Product Bulletin, "Getting The Most From Your Pulmonetic Systems' Batteries", for additional information on the proper use and management of external power sources.

Recognizing and Responding to the Situation

The ventilator is designed to detect conditions affecting proper ventilation and to provide both an audible and visual alarm/indicator to alert the caregiver to immediately respond to resolve the situation following the instructions listed below. The alarm indicators that will occur in the event that the device is not adequately powered by a stable external battery or automobile cigarette lighter accessory power outlet are described below. The caregiver will be able to immediately resolve the situation following the instructions listed below:

Vent Reset Alarm-

A vent reset alarm is identified by the following conditions:

First, the ventilator audible alarm will sound and all LED's (lights) on the front display panel will illuminate for approximately 1 second duration.

Next, for the next 3.5 seconds (approximate), the audible alarm will silence and the display on the front panel will flash the following text:
SRAM
ROM CRC
POST Passed

After displaying "POST Passed", the red Vent INOP LED on the ventilator front panel will be illuminated.

The Vent INOP light will go out, and the ventilator will repeat this entire Vent Reset Alarm sequence, audibly alarming every 3.5 seconds, until the external power cable is unplugged from the pigtail connector on the ventilator.

No ventilation is being delivered to the patient in this Vent Reset Alarm cycle.

If a Vent Reset Alarm occurs, immediately disconnect the external power cable from the ventilator pigtail connector. The ventilator will then revert to normal operation with power being supplied by the internal battery.

Or

Vent INOP Alarm-

A Vent INOP alarm is identified by the following conditions:

First, the front panel display indicators will light quickly and may go blank, or blink on and off continuously.

Next, the red Vent INOP LED (light) on the ventilator front display panel will be illuminated.

The audible alarm will sound continuously.

No ventilation is being delivered to the patient in this INOP alarm condition.

If a Vent INOP Alarm occurs, immediately disconnect the external power cable from the ventilator pigtail connector. If the ventilator does not immediately resume ventilation, restart (turn on) the ventilator by pressing the On/standby button on the front of the ventilator. The ventilator will then revert to normal operation with power being supplied by the internal battery.

Additional Instructions

In addition to these instructions, the following recommendations should be observed:

• The ventilator can be connected to the AC adaptor at any time after the DC power connection has been disconnected.
• If the Vent Reset or INOP alarm occurred while connected to an external battery, the battery should be replaced with a new battery prior to operation using the DC power connector.
• If the Vent Reset or INOP alarm occurred while connected to the Automobile Cigarette Lighter/Accessory Power Outlet, the automobile's electrical system may not be able to continuously supply the stable power required for ventilator operation. The ventilator should not be powered from that vehicle's electrical system. The ventilator can be powered by a new external battery for transport. When using the Automobile Cigarette Lighter/Accessory Power Outlet, always carry an external battery kit for emergency use.
• Do not use external batteries or DC power cables which have not been supplied or recommended by Pulmonetic Systems, Inc.
• Damaged power cables or batteries nearing end of life should be immediately removed from use.
• Follow Pulmonetic Systems, Inc. LTV^® Operators Manual (PN 10664) instructions regarding the use of external power sources.
• Please refer to the attached Product Bulletin for additional information on the proper use and care of external power sources.

The attached Caregiver Information Sheet is provided for your distribution to ventilator users affected by this Important Safety Information.

In addition, the company is investigating a number of longer term solutions that can be easily installed by the caregiver. Pulmonetic Systems, Inc. will contact you with further information regarding their availability.

Please contact Pulmonetic Systems, Inc. Technical Support @ 800-754-1914 Ext. 2 or 763-398-8500 Ext. 2, or service@pulmonetic.com for any questions regarding this information.

Attachments:

• LTV^® Series Caregiver Information Sheet
• Product Bulletin - Getting The Most From Your Pulmonetic Systems' Batteries (September 23, 2002)
• Affected Devices Serial Number Listing

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

VitalAire Canada Inc.
2000 Argentia Rd.
Plaza 2, Suite 200
Mississauga, ON
L5N 1V8
Telephone: 905-855-0414

Any suspected adverse incident 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.

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