Model Number 27033 |
Device Problems
Inadequate User Interface (2958); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2022 |
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 device was received by resmed and an evaluation confirmed the 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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Manufacturer Narrative
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Based on all available evidence and complaint investigations of a similar nature, the 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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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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Search Alerts/Recalls
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