Model Number 39001 |
Device Problem
Fire (1245)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2021 |
Event Type
malfunction
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Event Description
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It was reported to resmed that an airsense 11 power cord caught fire.There was no patient harm or a serious injury reported as a result of this incident.
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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.Resmed reference#: (b)(4).Pending evaluation.
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Manufacturer Narrative
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The airsense 11 device and power cord were returned to resmed for an investigation.Visual inspection revealed pinch points on the ac power cord, rough patches on the jacket of the ac power cord and no burn marks on the device or power supply unit.The device and power supply unit were performing to specifications with a known good ac power cord.Based on all available evidence, the investigation determined that the reported complaint was due to physical abuse.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 airsense 11 power cord caught fire.There was no patient harm or a serious injury reported as a result of this incident.
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Search Alerts/Recalls
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