Model Number 27053 |
Device Problems
Charging Problem (2892); Complete Loss of Power (4015)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/06/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device was returned to resmed and an evaluation confirmed the complaint.The power supply unit was replaced to address the issues.The device was serviced and fully tested before it was returned to the customer.Resmed reference#: (b)(4).
|
|
Event Description
|
It was reported to resmed that an astral device failed to charge its internal battery and shutdown unexpectedly.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.Review of the device data logs confirmed error messages (sf180) related to a battery charger fault and revealed the device shutdown due to a flat battery.Based on all available evidence and complaint investigations of a similar nature, the investigation determined sf180 was due to the device operating in high ambient temperatures.Resmed¿s risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference#: (b)(4).
|
|
Event Description
|
It was reported to resmed that an astral device failed to charge its internal battery and shutdown unexpectedly.There was no patient harm or serious injury reported as a result of this incident.
|
|
Search Alerts/Recalls
|