Model Number 27003 |
Device Problems
Premature Discharge of Battery (1057); Protective Measures Problem (3015)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/31/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device was returned to resmed and an evaluation confirmed the complaint.The main circuit board and pneumatic block were replaced to address this issue.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 displayed an error message (sf131) related to the main blower temperature sensor.There was no patient harm or serious injury reported as a result of this incident.
|
|
Manufacturer Narrative
|
During evaluation, the reported internal battery with a reduced level of capacity could not be confirmed.Visual inspection of the device revealed a black substance within the device.Based on all available evidence and complaint investigations of a similar nature, an investigation determined that the reported sf131 was due to contamination of the device.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 displayed an error message (sf131) related to the main blower temperature sensor and had an internal battery with a reduced level of capacity.The device was not in patient use when the reported event occurred.
|
|
Search Alerts/Recalls
|