Model Number PT101 |
Device Problems
Defective Alarm (1014); No Audible Alarm (1019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The subject device is no longer in use by the healthcare facility.The complaint device is in transit to fisher & paykel healthcare for evaluation.We will provide a follow up report upon completion of our investigation.Product background: the pt101 airvo 2 humidifier (airvo 2) device is an active humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.It's intended use is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.
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Event Description
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A healthcare facility in maryland reported via a fisher & paykel healthcare field representative that the audible alarm of a pt101 airvo 2 humidifier was not functioning as expected.There was no reported patient involvement.
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Manufacturer Narrative
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(b)(4).Product background: the pt101 airvo 2 humidifier (airvo 2) device is an active humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.It's intended use is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.Method: the complaint airvo 2 was received by fisher & paykel healthcare (f&p) where it was inspected by a trained f&p employee.The device was performance tested and the audible alarm function was checked.Results: performance testing revealed that the audible alarm of the airvo 2 unit was working.Conclusion: we are unable to determine what may have caused the reported failure as there was no fault found with the returned device.
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Event Description
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A healthcare facility in maryland reported via a fisher & paykel healthcare field representative that the audible alarm of a pt101 airvo 2 humidifier was not functioning as expected.There was no reported patient involvement.
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Search Alerts/Recalls
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