Model Number 24146 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Loss of consciousness (2418)
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Event Type
malfunction
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Manufacturer Narrative
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Resmed has requested for the device to be returned so that an investigation could be performed.The device has not been returned, therefore resmed is unable to confirm the alleged malfunction at this time.(b)(4).
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Event Description
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It was reported to resmed that a patient had impaired consciousness while using a stellar 150 device and was taken to a hospital.It was reported that the device had been dropped by the caregiver prior to the event.The patient has recovered but remains in the hospital.
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Manufacturer Narrative
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The stellar device was returned to resmed for an investigation.The investigation determined that there was no fault found with the returned device.The device was performing to specifications.Resmed's risk analysis for the use of this device remains unchanged and acceptable.Resmed reference #: (b)(4).
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Event Description
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It was reported to resmed that a patient had impaired consciousness while using a stellar 150 device and was taken to a hospital.It was reported that the device had been dropped by the caregiver prior to the event.The patient has recovered but remains in the hospital.
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Search Alerts/Recalls
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