Model Number 27003 |
Device Problems
Failure to Charge (1085); Device Displays Incorrect Message (2591)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/21/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned to resmed and an evaluation confirmed the reported battery error message and could not reproduce the reported device failed to charge its internal battery.The internal battery was replaced to address this issue.The device was serviced and fully tested before it was returned to the customer.Resmed reference#: (b)(4).
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Event Description
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It was reported to resmed that an astral device displayed a battery error message and failed to charge its internal battery.There was no patient involvement reported.
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Manufacturer Narrative
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The astral device was returned to resmed for an investigation.Review of the device data logs confirmed the reported complaint.Based on all available evidence and complaint investigations of a similar nature, the investigation determined that the reported battery error message was due to an intermittent connection with the battery while the battery charger fault alarms were due to device operation in a temperature outside of the device specification.Resmed¿s risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference: (b)(4).
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Event Description
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It was reported to resmed that an astral device displayed a battery error message and failed to charge its internal battery.There was no patient involvement reported.
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Search Alerts/Recalls
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