Astral 100 and Astral 150 ventilators

Recall for product correction - risk of insufficient ventilation and expiratory pressure if disconnection alarms are disabled

15 May 2015

Consumers and health professionals are advised that ResMed, in consultation with the TGA, has initiated a recall for product correction in relation to its Astral 100 and Astral 150 ventilators due to the capacity to disable the disconnection alarm in situations where disabling that alarm should not occur.

Astral 100 and Astral 150 ventilators provide support to patients with respiratory difficulties due to health conditions of varying severity. They can be used in both health facilities and home settings.

astral ventilator machineThese ventilators have various programmable alarms, including an alarm that sounds if the device becomes disconnected from the patient. This alarm's settings can be modified by health professionals, but cannot be changed by patients in their home.

When the ventilator is used non-continuously for lower dependency patients, health professionals can disable its disconnection alarm. However, this alarm should not be disabled when the device is used continuously for high-dependency patients.

RedMed initiated the recall for product correction following a single incident overseas, in which an Astral ventilator had been disconnected from a high-dependency patient without an alarm sounding. It was later found that a health professional had disabled all of the alarms that would normally indicate disconnection.

While the patient did not suffer serious injury, this situation could have resulted in the patient receiving insufficient ventilation or experiencing insufficient expiratory pressure, which could have caused serious harm.

There have been no reports of similar incidents in Australia.

ResMed is developing updated software for Astral ventilators in which the disconnection alarm cannot be deactivated for any ventilation mode used with high-dependency patients. The company plans to begin implementing the software update later this year.

In the meantime, ResMed is providing health professionals information to reduce these risks to patients.

Information for consumers

ResMed has written to health facilities and distributors providing further information and asking them to notify all users of Astral 100 and Astral 150 ventilators of this issue.

ResMed advises that, as long as the disconnection alarm is not disabled for high-dependency patients who are using the device continuously, as directed in the Instructions for Use, the above safety concern will not occur.

Alarm configurations can only be changed by health professionals and cannot be modified by the patient in the home. The settings and effective operation of alarms need to be tested when the device is set up for each patient, after any change to the way it is being used or introduction of additional therapies, and after any change of carer.

If you or someone you care for uses an Astra 100 or Astra 150 ventilator and you questions or concerns about this issue, contact the supplier of your device. Alternatively, contact ResMed on 02 8884 1000 or email info@sleepvantage.com.au.

Information for health professionals and health facilities

ResMed has written to health facilities and distributors providing further information and asking them to notify all users of Astral 100 and Astral 150 ventilators of this issue.

ResMed plans to begin implementing a software update to address these issues later this year. In the meantime, you should ensure that alarms are appropriately set up for high-dependency patients and be aware of safety information relating to alarms in the Instructions for Use.

The settings and effective operation of alarms need to be tested when the device is set up for each patient, after any change to the circuit, ventilation settings or co-therapy, and after any change of carer. As long as the Instructions for Use are adhered to, the above safety concern will not occur.

If you have any questions or concerns about this issue, contact the supplier of the ventilator or contact ResMed on 02 8884 1000 or email info@sleepvantage.com.au.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.