Model Number 27074 |
Device Problems
Inadequate User Interface (2958); Operating System Becomes Nonfunctional (2996)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/15/2022 |
Event Type
malfunction
|
Manufacturer Narrative
|
The astral device was returned to resmed.Evaluation confirmed the reported complaint.The main circuit board was replaced to address the issue.The device was serviced and fully tested before it was returned to the customer.Resmed reference#: (b)(4).
|
|
Event Description
|
During resmed evaluation, an astral device had an unresponsive, frozen touchscreen.There was no patient harm or serious injury reported as a result of this incident.
|
|
Event Description
|
During resmed evaluation, an astral device had an unresponsive, frozen touchscreen.There was no patient harm or serious injury reported as a result of this incident.
|
|
Manufacturer Narrative
|
Based on all available evidence, the investigation determined that the reported complaint was due to contamination of the main circuit board.Resmed¿s risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).
|
|
Search Alerts/Recalls
|