Model Number 33113 |
Device Problem
Fire (1245)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/26/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device was returned to resmed for an engineering investigation.The investigation methods, results and conclusion are not finalized at this stage.When more information is available, a supplemental report will be submitted.(b)(4).Pending evaluation.
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Event Description
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It was allegedly reported to resmed that an s8 autoset device caught fire.There were no reports of a serious injury or any kind of medical attention sought by the patient.
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Event Description
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It was allegedly reported to resmed that an s8 autoset device caught fire.There were no reports of a serious injury or any kind of medical attention sought by the patient.
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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 root cause was mechanical deterioration of the ac appliance inlet connector solder joint in the power supply unit.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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