Alerte De Sécurité sur LTV Series Continuous Fans (1) Model LTV 800, (2) Model LTV 900, (3) Model LTV 950, (4) Model LTV 1000, Anvisa registry nº 10349590042 - Units distributed between September 2003 and January 2008.

Safety alert

918

2008-05-12

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

Cardinal health has received numerous reports of printed circuit board malfunction in the above mentioned fans as a result of failure of an electronic component. this malfunction may cause the ventilator to not give the patient appropriate breathing and / or failure to produce the appropriate alarm (producing an inaudible, intermittent, or distorted alarm) to alert the patient care team, which could result in injury or death of the patient if auxiliary ventilation was not administered by the team in charge. cardinal health received no reports of malfunctioning of these ventilators that had resulted in failure to provide adequate ventilation without producing an audible alarm to alert employees to patient care. the company has established that, although this simultaneous malfunction is possible, this is very unlikely to happen. the manufacturer initiated a correction through a letter from "urgent medical device recall", dated february 22, 2008.

Check receipt of the February 22, 2008 "Urgent Medical Device Recall" letter and the Cardinal Health serial number list. Identify and separate any affected product from your inventory using the list of serial numbers. Cardinal Health will correct the affected product at no cost. To return the affected product, contact the customer service department who will provide the address of your local service center. All ventilator dependent patients should be continuously monitored by qualified personnel following clinical practice and ventilator use instructions to ensure that alternate ventilation can be provided if a malfunction occurs until the product is repaired. Both the fan operation and audible alarm operation must be checked daily. To verify the proper functioning of the audible alarm, proceed as follows: 1. If the Ventilator is operated externally with alternating current (AC) or battery, momentarily turn off the ventilator from the external power source. Check that the audible alarm is heard and the Fan shows "Power Lost" on the display. Turn on the external power source again and check that the alarm is silent and that the light emitting diode (LED) of the external power source is lit. Press the "Silence Reset" button so that the fan display returns to its normal operation. 2. If the ventilator is operated by an internal battery, first connect the Ventilator to an external AC power source or the external battery and then disconnect it from the external power source. Check that the alarm sound is heard and that "Power Lost" is displayed on the fan display. Press the "Silence / Return" button twice, bringing the fan display to normal operation. Note that the internal battery is intended for use for short periods while switching between connections from external sources, in emergency situations or for short periods of transport. Connect the fan to an external AC source or external DC power as soon as possible. Ventilation is not interrupted during this check or proof of alarm operation. To check the fan operation, with the fan "ON" and connected to the patient, visually check that the display on the front panel of the ventilator does not indicate any change in the alarm. If the fan fails exactly during the verification of its operation or during the verification of the alarm operation, the equipment must be withdrawn from use and another fan must be connected to the patient.