Stellar 100 and Stellar 150 (2019-12-05)

Starting date:

December 5, 2019

Posting date:

December 20, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-71937

Last updated: 2019-12-20

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  Reason
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  Affected products

Affected Products

Stellar 100 and Stellar 150

Reason

Resmed received a confirmed case of an alarm buzzer not working under the following circumstances:  the device has a failed electronic component and, the device is stored without AC power connected for more than 36 hours leading to full depletion of the battery and, the device powers on automatically when connected to AC power without pressing the power switch.  The identified issue is a combination of software and a component failure that may occur in a small number of devices.  If a device with is issue is used in the condition described above, the audible alarms may not operate properly.

Affected products