Pulmonary Ventilator Ventilator Circuit. Temperature Transducer (Heated-Wire) In the Ventilator Ventilator Circuit. Coded Products: (1) 780-19, 780-20,780-31 to 780-36,780-51, 780-52, 790-52; (2) 780-23 to 780-25, 780-30; (1 and 2) Lots # 42012 and below; products manufactured before October 15, 2001; units distributed within the US and internationally 의 안전성 경고

Safety alert

272

2002-01-25

Brazil

ANVISA

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

The above mentioned fan circuit may have a manufacturing defect (series / batch). in some cases, the cable connector used to secure / hold the guidewire close to the patient, on the y connection, may not have been mounted correctly. this may result in a malfunction in the wire / cable heater. the manufacturer commenced a voluntary correction work through the urgent correction process with a letter dated october 12, 2001.

Make sure you have received the letter and the white posting card for Hudson RCI return. Identify, isolate, and immediately discontinue use of the affected product in your inventory. The manufacturer recommends follow-up to reduce the possibility of sparking, overheating and / or ignition with the circuit. The following measures are recommended: (1) The wire / cable circuit should never be stretched or with high condensation / secretion. (2) Do not use the breathing circuit for more than 5 days. Complete all required information on the prepaid white return card if you have or have any affected product in your inventory, and return the prepaid return card to Hudson RCI by mail to the address or fax at 1 (909) 676 -1578. For more information on how to return the affected product, obtain the authorization number, or more information, contact your local Hudson RCI representative or directly at 1 (909) 676-5611 in the USA.