Model Number HC300 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Dyspnea (1816)
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Event Date 09/16/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint hc300 humidification chamber is currently en route to fisher and paykel healthcare (f&p) for investigation.We will provide a follow up report upon completion of our investigation.
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Event Description
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A healthcare facility in sweden reported, via a fisher and paykel healthcare (f&p) field representative, that a hc300 humidification chamber had not been correctly assembled after cleaning.This resulted in the water in the chamber to leak out.Once all the water had leaked out, air began to leak out of the chamber, resulting in a low tidal volume provided to the patient.The ventilator alarmed, alerting the patient to the leak.The patient experienced dyspnea.No further patient consequences were reported.
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Event Description
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A regulatory body, on behalf of a healthcare facility, reported that the hc300 humidification chamber had not been correctly assembled after cleaning.This resulted in the water in the chamber to leak out.Once all the water had leaked out, air began to leak out of the chamber, resulting in a low tidal volume provided to the patient.The ventilator alarmed, alerting the patient to the leak.The patient experienced dyspnea.The patient pushed the button for help when the ventilator alarmed, and the chamber was reassembled by staff immediately.No further patient consequences were reported.
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Manufacturer Narrative
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(b)(4).Method: method: the complaint hc300 humidification chamber was received at fisher & paykel healthcare (f&p) new zealand, where it was visually inspected and tested.Results: performance testing of the complaint hc300 humidification chamber revealed the chamber to be sealing properly and no leaks were observed.Conclusion: no fault was found with the hc300 humidification chamber.It was noted that the customer reported that the chamber base had not been assembled correctly after cleaning, resulting in the reported water leak.
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Search Alerts/Recalls
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