MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AIRVO 2 HUMIDIFIER

Model Number PT101

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Death (1802); Virus (2136); Viral Infection (2248); Low Oxygen Saturation (2477)

Event Date 10/13/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).The complaint pt101 airvo 2 humidifier is currently en route to fisher & paykel healthcare (f&p) for evaluation to determine the involvement of our product in the reported event.We are also currently in the process of obtaining further information from the customer.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a "severely unwell" covid-19 patient was being aspirated for a pneumothorax and desaturated to spo2 68%.It was reported that the airvo 2 generated an e180 alarm at the time.The airvo 2 was set to adult mode with flow settings set at 60lpm and 37 c, and fio2 set at 84%.The patient was then transferred to another airvo 2 humidifier.The patient's spo2 level increased to 92% and continued therapy.The patient deceased the following day.The healthcare facility noted they do not believe the airvo 2 caused or contributed to reported death but reported the patient's current condition.

Manufacturer Narrative

(b)(4).Method: the complaint airvo 2 was received at f&p new zealand where it was visually inspected.The healthcare facility reported that a "severely unwell" covid-19 patient required aspiration for a pneumothorax.The hospital reported the following sequence of events: the patient was set up on an airvo 2 which was in adult mode and flow settings set at 60lpm and 37 c and fio2 set at 84%.The patient was set-up on this device for 2 days.On the 13th october 2020 at 1700 hours, it was reported that the airvo 2 generated an e180 alarm while a healthcare professional was performing an aspiration for a pneumothorax on the patient.The patient desaturated to 68% spo2.The patient was then transferred to another airvo 2.The patient's spo2 level increased to 92% and continued therapy.On the (b)(6) 2020, the patient passed away.The healthcare facility noted they do not believe the airvo 2 caused or contributed to the reported death.Results: visual inspection of the complaint unit, the initial unit which the patient was set-up on, revealed no visible damages.Review of the log identified that the e180 error code occurred at approximately 1656 hours on (b)(6) 2020 and was recorded four times, which is consistent with the events reported by the hospital.It should be noted that the second airvo 2 was not returned to f&p new zealand as there was no fault reported with the device.The e180 error code can occur when there is a partial blockage of the flow or a rapid increase in the oxygen flow rate to the device.When an e180 alarm is triggered an audible alarm will sound and a visual alarm will display 'fault e180' and 'switch off the unit and then restart'.Conclusion: based on the device analysis and additional information provided by the customer, the most likely cause of the airvo 2 alarming for e180 was due to an unintentional partial blockage of the flow during the pneumothorax aspiration.As part of the investigation the information was assessed, and it was determined that the patient's clinical condition was unstable prior to the event.The healthcare facility noted they do not believe the airvo 2 caused or contributed to the reported death.The airvo 2 is designed to provide humidification therapy to spontaneously breathing patients who are not dependent on mechanical respiratory support.The airvo 2 user instruction specifies the following information: "do not block the flow of air through the unit and breathing tube." "the unit is not intended for life support." "appropriate patient monitoring must be used at all times." "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption of their oxygen supply.".

Event Description

A healthcare facility in northern ireland reported via a fisher & paykel healthcare (f&p) field representative that a "severely unwell" covid-19 patient was being aspirated for a pneumothorax and desaturated to spo2 68%.It was reported that the airvo 2 generated an e180 alarm while a healthcare professional was performing an aspiration for a pneumothorax on the patient.The airvo 2 was set to adult mode with flow settings set at 60lpm and 37 c, and fio2 set at 84%.The patient was then transferred to another airvo 2.The patient's spo2 level increased to 92% and continued therapy.The patient deceased the following day.The healthcare facility noted they do not believe the airvo 2 caused or contributed to the reported death but reported the patient's current condition.

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: AIRVO 2 HUMIDIFIER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 10819881
• MDR Text Key: 215959042
• Report Number: 9611451-2020-00994
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422354
• UDI-Public: (01)09420012422354(10)2100849596(11)190812
• Combination Product (y/n): N
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 2100849596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: F&P 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT; F&P 900PT561 HEATED BREATHING TUBE AND CHAMBER KIT; F&P OPT944 OPTIFLOW ADULT NASAL CANNULA; F&P OPT944 OPTIFLOW ADULT NASAL CANNULA
• Patient Outcome(s): Death; Other