Model Number PT101 |
Device Problem
Device Handling Problem (3265)
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Patient Problem
Low Oxygen Saturation (2477)
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Event Date 12/02/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).We are currently in the process of retrieving further information and complaint airvo pt101 device from the hospital.We will provide a follow up report upon completion of our investigation.
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Event Description
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A hospital in the (b)(6) reported via a fisher and paykel healthcare (f&p) representative that an incident involving pt101 airvo 2 humidifier and a third-party ups (tripplite) for transportation of a patient occurred.We were informed that during transfer of a patient from the hospital into an ambulance, the airvo unit was connected to a third-party ups via a third-party connector.The baby was on 8l/min flow and no oxygen when the transfer began however the flow was fluctuating and not remaining at 8l/min so oxygen was added.The patient desaturated down to 67%.Immediately after the event, the airvo unit was transferred from the third-party ups power supply to mains power.No further patient consequences were reported.
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Manufacturer Narrative
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(b)(4).The complaint pt101 airvo humidifier was returned to fisher & paykel healthcare in new zealand for evaluation.The device was performance tested.The reported fault could not be replicated and there was no fault found with the complaint device.The unit was run continuously for an extended test period.The flow was consistent at 8l/min for the entire run time.Please note the airvo user manual instructs the user to "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply." the airvo user manual also states that the "airvo is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases." finally, the user manual also warns the user: the unit is not intended for life support.Appropriate patient monitoring must be used at all times.
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Event Description
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A hospital in the uk reported via a fisher and paykel healthcare (f&p) representative that an incident involving pt101 airvo 2 humidifier and a third-party ups (tripplite) for transportation of a patient occurred.We were informed that during transfer of a patient from the hospital into an ambulance, the airvo unit was connected to a third-party ups via a third-party connector.The baby was on 8l/min flow and no oxygen when the transfer began however the flow was fluctuating and not remaining at 8l/min so oxygen was added.The patient desaturated down to 67%.Immediately after the event, the airvo unit was transferred from the third-party ups power supply to mains power.The patient was then transferred directly onto oxygen and adrenaline was administered.The patient recovered and the hospital proceeded with the ambulance transfer.No further patient consequences were reported.
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Search Alerts/Recalls
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