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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AIRVO2 HUMIDIFIER
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FISHER & PAYKEL HEALTHCARE LTD AIRVO2 HUMIDIFIER Back to Search Results
Model Number PT101
Device Problem Device Handling Problem (3265)
Patient Problem Low Oxygen Saturation (2477)
Event Type  malfunction  
Manufacturer Narrative
(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.
 
Event Description
It was reported by mhra on behalf of a healthcare facility that an airvo was found to be operating on junior mode on an adult patient.The reason was unknown at the time of the incident.The nurse in charge of the patient changed the airvo back to adult mode by following instructions on instruction card.The flow was increased back up to 60lpm but airvo continued to deliver lower flow rate to patient.The airvo was pulled out for further investigation at the hospital.We were further informed that the patient died but this incident did not in any way contribute to the patient's death.
 
Manufacturer Narrative
(b)(4).Following this complaint, we sought further information from the hospital, we were informed that the device was delivering low flow rates because it was found to be in the wrong mode (paediatric mode), the device was then changed back to default/adult mode and a flow rate of 60l and then 50l was set.No further issues were reported with airvo unit after the mode was changed.The hospital also confirmed that the patient died later, however, this incident did not in any way contribute to the patient's death.Conclusion: user error contributed to this event.The unit was changed to paediatric mode unknowingly during therapy which led to patient desaturation.The hospital did not confirm "how" the mode got changed.Following the incident, the unit was taken to the clinical engineering department at the hospital.We were informed that unit was working correctly and has now locked out paediatric mode on their devices.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 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.".
 
Event Description
It was reported by mhra on behalf of a healthcare facility that an airvo was found to be operating on junior mode on an adult patient.The reason was unknown at the time of the incident.The nurse in charge of the patient changed the airvo back to adult mode by following instructions on instruction card.The flow was increased back up to 60lpm but airvo continued to deliver lower flow rate to patient.The airvo was pulled out for further investigation at the hospital.We were further informed that the patient died but this incident did not in any way contribute to the patient's death.
 
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Brand Name
AIRVO2 HUMIDIFIER
Type of Device
AIRVO2 HUMIDIFIER
Manufacturer (Section D)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland, 2013
NZ  2013
MDR Report Key8098175
MDR Text Key128410017
Report Number9611451-2018-00991
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
PMA/PMN Number
K131895
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPT101
Device Catalogue NumberPT101
Device Lot Number2100009000
Was Device Available for Evaluation? No
Date Manufacturer Received10/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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