Model Number PT101 |
Device Problems
No Audible Alarm (1019); Inaudible or Unclear Audible Prompt/Feedback (2283)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint airvo humidifier is expected but has not yet been returned to fisher & paykel healthcare in (b)(4) for evaluation.We will submit a follow up report upon completion of our investigation.
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Event Description
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A hospital in (b)(6) reported the speaker of a pt101 airvo 2 humidifier was not working properly.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).Method: the complaint pt101 airvo humidifier was returned to fisher & paykel healthcare (f&p) in new zealand and was visually inspected and electrically tested.Results: during testing it was found that the visual alerts on the complaint airvo were operating, however no audible alarm was heard.The fault was traced to a faulty speaker and electrical resistance testing showed that the speaker's resistance was open circuit.Conclusion: as part of our ongoing product improvement initiatives, we have implemented a soak test for 100% testing of the speaker harness on the airvo production line, which identifies and discards any faulty speakers prior to assembly into the airvo.Additionally, a new speaker unit has more recently been sourced from a different supplier.The subject airvo was manufactured prior to implementation of these measures.The airvo user manual states that the "airvo is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases." and that " the unit is not intended for life support." the user manual warns the user: - prior to each patient use, ensure that the auditory alarm signal is audible by conducting the alarm system functionality check described in the alarms section.The alarm system functionality check instructs the user on how to check the alarm and states that "if either alarm signal is absent, do not use the unit.Contact your fisher & paykel healthcare representative.".
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Event Description
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A hospital in canada reported the speaker of a pt101 airvo 2 humidifier was not working properly.There was no patient involvement.
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Event Description
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A hospital in canada reported the speaker of a pt101 airvo 2 humidifier was not working properly.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).Correction: amended conclusion code from 4307 cause traced to component failure to 11 conclusion not yet available.The complaint airvo humidifier is expected but has not yet been returned to fisher & paykel healthcare in new zealand for evaluation.We will submit a follow up report upon completion of our investigation.
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Search Alerts/Recalls
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