Model Number 27052 |
Device Problems
Premature Discharge of Battery (1057); Battery Problem (2885); Inadequate User Interface (2958); Power Problem (3010)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/30/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device was returned to resmed and an evaluation confirmed the complaint.The top case , main circuit board and internal battery required replacement to address the issues.The device was deemed beyond repair and scrapped.Resmed reference#: pr (b)(4).
|
|
Event Description
|
It was reported to resmed that an astral device had a defective display, power source detection issue and an internal battery with a reduced level of capacity.There was no patient harm or serious injury reported as a result of this incident.
|
|
Event Description
|
It was reported to resmed that an astral device had a defective display, power source detection issue and an internal battery with a reduced level of capacity.There was no patient harm or serious injury reported as a result of this incident.
|
|
Manufacturer Narrative
|
The astral device was returned to resmed for an investigation.Signs of physical damage were observed on the device.Review of the device data logs revealed an internal battery degraded warning alarm.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported display issue was due to physical damage while the internal battery degraded warning alarm was due to the battery controller software and the power source issue was due to soldering process during manufacturing.Resmed's risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).
|
|
Search Alerts/Recalls
|