Safety Alert for Trade name: Ventilator /// Anvisa Registration n ° 80047300528 /// Technical name: Fan Pressure and Volume /// Risk class: III (High Risk) ///; Affected model (s): Astral 100 / Astral 150 /// Serial number (s) affected: See Annex.

Safety alert

1994

2016-09-06

Brazil

ANVISA

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

When astral fans are used with the internal battery as their only electrical source, it is important to note that internal battery failure can lead to interruption of treatment without "battery low" or "critically poor battery" alarms even firing battery is charged. in such cases, ventilator-dependent patients (patients unable to maintain adequate ventilation without assistance and deteriorating conditions) may be at risk if no urgent action is taken to restore energy or to initiate an alternative form of ventilation. resmed received a small number of reports (<0.1% of handsets sold globally) of a performance problem associated with the astral 100 and 150's internal batteries. although these events are extremely rare, it is important that you follow the important ones you follow the precautions described in the astral labeling and this fsn.

Field Action code 9 triggered under the responsibility of the company MEDSTAR IMPORTAÇÃO E EXPORTAÇÃO LTDA. Company issued Safety Alert with precautions to be taken by users, caregivers and health care workers Precautions to be taken by users / caregivers in the home or health / hospital environment 1.Connect the ventilator to electrical power via alternating current whenever possible. In the event of a battery failure, connect the device to the AC source immediately to resume ventilation. 2. If possible, use an external power source (external Astral battery or RPSII battery) for ventilation dependent patients. 3. If possible, use an external power source (Astral external battery or RPSII battery) in mobile situations, including when AC power is unavailable or is interrupted. Do not rely solely on the internal battery for mobile use. 4. Ensure that the external battery source is sufficiently charged before using the equipment in mobile situations. 5. When treating ventilator-dependent patients, always have alternative ventilation equipment available, such as a back-up ventilator, manual resuscitator, or similar device. 6. Ventilation dependent patients should be continuously monitored by qualified personnel or appropriately trained caregivers. Such persons and caregivers should be able to take corrective action in the event of a malfunction of the ventilator alarm. 7. Follow Astral's maintenance service plan every two years. At this point, the internal battery will be replaced. 8.Equipments with batteries approaching two years of use and with frequent battery depletion should be monitored for battery performance verification in accordance with the operating instructions, including a periodic check that the battery has adequate charge capacity. Batteries that have reduced performance performance should be replaced immediately. 9. Return the equipment to a Service Center if it presents any reports of battery problems or significant degradation of battery performance.