Model Number 27074 |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Low Oxygen Saturation (2477)
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Event Date 04/24/2023 |
Event Type
Injury
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Manufacturer Narrative
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The astral device was returned to resmed.The investigation methods, results, and conclusions are not finalized at this stage.If further information becomes available, a supplementary report will be submitted.Resmed reference#: pr (b)(4).
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Event Description
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It was reported to resmed that a hospitalized patient experienced severe desaturation of blood oxygen allegedly due to an astral 150 device unexpectedly stopped ventilation.The patient was removed from the device and placed an alternate device.The patient has recovered.
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Manufacturer Narrative
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The astral 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 associated with use of the device remains acceptable.The astral 100/150 user guide provides the following warnings: ¿for ventilator-dependent patients, always have alternate ventilation equipment available, such as a back-up ventilator, manual resuscitator or similar device.Failure to do so may result in patient injury or death.Ventilator-dependent patients should be continuously monitored by qualified personnel or adequately trained carers.These personnel and carers must be capable of taking the necessary corrective action in the event of a ventilator alarm or malfunction.¿ resmed reference#: (b)(4).
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Event Description
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It was reported to resmed that a hospitalized patient experienced severe desaturation of blood oxygen allegedly due to an astral 150 device unexpectedly stopped ventilation.The patient was removed from the device and placed an alternate device.The patient has recovered.
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Search Alerts/Recalls
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