Device product
ResMed Stellar, Non-invasive/invasive ventilators, Model: 100, 150
Z-0915-2020
Product summary
- Firm
- ResMed Ltd.
- Event
- Event 84551
- Status
- Completed
- Classification
- Class I
- Quantity
- 69
- Official record key
device-enforcement:Z-0915-2020
Official wording
Reason: Combination of software and a component failure may cause audible alarms not to operate properly, the alarm buzzer not work, for ventilators that have a failed electronic component and, that are stored without AC power connected for more than 36 hours leading to full depletion of the battery and, that powers on automatically when connected to AC power without pressing the power switch.
Code information: Serial Number Range: 20160123307 to 22171057208
Distribution pattern: U.S.: PA, MA, VA, TN, CT, IL, GA, FL, MT
Derived failure modes
-
Device software or design
software and a component failure