Model Number 27088 |
Device Problems
Inadequate User Interface (2958); Operating System Becomes Nonfunctional (2996)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/19/2022 |
Event Type
malfunction
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Event Description
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It was reported to resmed that an astral device had an unresponsive touchscreen.There was no patient harm or serious injury reported as a result of this incident.
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Manufacturer Narrative
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The astral device was returned to resmed.Evaluation confirmed the reported complaint.The top case was replaced to address the 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 had an unresponsive touchscreen.There was no patient harm or serious injury reported as a result of this incident.
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Manufacturer Narrative
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Based on all available evidence and complaint investigations of a similar nature, an investigation determined that the touchscreen issue was due to a manufacturing defect.The reportable event occurred outside the us.During a routine check of complaints records it was detected that the event is reportable in the us.This report is being submitted to correct the error.Resmed¿s risk analysis for this failure mode concludes that the risk is acceptable.Resmed reference #: (b)(4).
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Search Alerts/Recalls
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