Model Number PT101 |
Device Problems
Device Emits Odor (1425); Sparking (2595)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint pt101 airvo 2 humidifier and plug are currently en route to fisher & paykel healthcare (f&p) for evaluation to determine if our product caused or contributed to the reported event.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 (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that the plug of a pt101 airvo 2 humidifier made a spark at the ac outlet and a burning smell was noted when the plug was plugged in.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).Method: the complaint airvo humidifier was not received at fisher & paykel healthcare (f&p) for evaluation.Investigation is thus based on information provided by the customer and our knowledge of the product.Results: the customer reported that the plug of a pt101 airvo 2 humidifier made a spark at the ac outlet and a burning smell was noted when the plug was plugged in.Conclusion: without the complaint device, we are unable to determine what caused the reported failure.The airvo 2 humidifier is designed to the electrical safety standards, iec 60601-1 and can/csa-c22.2 no.60601-1.The user instructions that accompany the airvo 2 humidifier include the following warning: "never operate the unit if it has a damaged power cord or plug" "avoid unnecessary removal of the power cord from the rear of the device.If removal is necessary, hold the connector during removal.Avoid pulling on the power cord.".
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Event Description
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A healthcare facility in canada reported via a fisher & paykel healthcare (f&p) field representative that the plug of a pt101 airvo 2 humidifier made a spark at the ac outlet and a burning smell was noted when the plug was plugged in.There was no patient involvement.
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Search Alerts/Recalls
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