Model Number 28306 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
Insufficient Information (4580)
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Event Type
Death
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Event Description
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It was reported to resmed that a patient receiving therapy from a lumis 100 vpap st device was found expired with the device powered off.
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Manufacturer Narrative
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Resmed has requested for the device to be returned so that an engineering investigation can be performed.The device has not been returned, therefore, resmed is unable to confirm the alleged malfunction at this time.The lumis 100 vpap st user guide provides the following indications for use: ¿the lumis 100 vpap st device is indicated to provide non-invasive ventilation for patients weighing more than 13 kg with respiratory insufficiency or obstructive sleep apnea (osa).It is intended for home and hospital use.¿ it is only intended to provide ventilation to a spontaneously breathing patient as it is not a life support ventilator.The user guide also provides the following warning: - ¿the device is not suitable for ventilator dependent patients.¿ resmed reference#: (b)(4).
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Event Description
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It was reported to resmed that a patient receiving therapy from a lumis 100 vpap st device was found expired with the device powered off.
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Manufacturer Narrative
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The lumis 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.Review of the device data logs revealed on the day of the reported event, smart start function was disabled which requires initiation of therapy by manually pressing the start button.The lumis 100 vpap st user guide provides the following indications for use: - ¿the lumis 100 vpap st device is indicated to provide non-invasive ventilation for patients weighing more than 13 kg with respiratory insufficiency or obstructive sleep apnea (osa).It is intended for home and hospital use.¿ it is only intended to provide ventilation to a spontaneously breathing patient as it is not a life support ventilator.The user guide also provides the following warning: - ¿the device is not suitable for ventilator dependent patients.¿ resmed¿s risk associated with use of the device remains acceptable.Resmed reference#: (b)(4).
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Search Alerts/Recalls
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