Model Number 37207 |
Device Problem
Fire (1245)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/26/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device was received by resmed without the power cord.An evaluation was performed, however, since incomplete device was returned, resmed is unable to confirm the alleged malfunction at this time.The customer was provided a replacement device.Resmed reference#: (b)(4).
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Event Description
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It was reported to resmed that the power cord of an airsense 10 device caught fire.The device was not in patient use when the reported event occurred.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 received by resmed and an evaluation was performed.The reported complaint could not be confirmed during evaluation.An investigation determined that there was no fault found with the returned device.The device was performing to specifications.Resmed¿s risk associated with use of the device remains acceptable.Resmed reference#: (b)(4).
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Event Description
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It was reported to resmed that the power cord of an airsense 10 device caught fire.The device was not in patient use when the reported event occurred.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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