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); Protective Measures Problem (3015)

Patient Problem Low Oxygen Saturation (2477)

Event Type  Injury  

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a sedated, non-responsive patient was admitted to the post anaesthesia care unit (pacu).The patient had desaturated to 70% spo2 and was then provided with alternative oxygen therapy prior to being placed on a pt101 airvo 2 humidifier (airvo 2).It was further reported that the airvo 2 was set to 50l/min flow and 100% o2; however, the patient's spo2 levels did not initially respond when placed on the airvo 2.The healthcare facility reported that the airvo 2 generated an e192 error code and was replaced with another airvo 2 device set to 50l/min flow and 100% o2 which generated the same error code.It was further reported that the patient was critically unwell, in respiratory arrest, and was intubated for three days in the intensive care unit (icu).The patient has since been extubated and transferred out of icu into the ward, with no further reported consequences.

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of obtaining further information regarding the reported event.We have also requested the return of the two subject pt101 airvo 2 humidifiers to f&p (b)(4) for evaluation.We will provide a follow up report upon completion of our investigation.Device a - batch number: 2100017808, serial number: (b)(4), date of manufacturing: 13 jan 2016, udi: (b)(4).Device b - batch number: 2100017808, serial number: (b)(4), date of manufacturing: 13 jan 2016, udi: (b)(4).

Manufacturer Narrative

(b)(4).Section d4: pt101 airvo 2 (device a) - batch number: 2100017808, serial number: (b)(6) date of manufacturing: 13 jan 2016, udi: (b)(4) pt101 airvo 2 (device b) - batch number: 2100017808, serial number: (b)(6), date of manufacturing: 13 jan 2016, udi: (b)(4).Product background: the pt101 airvo 2 humidifier (airvo 2) device is an active humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.Its intended use is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.Method: the two subject airvo 2 devices were received at fisher & paykel healthcare (f&p) in new zealand where they were visually inspected and performance tested.An investigation was carried out by f&p which was based on the information provided by the healthcare facility, our evaluation of the returned devices, and our knowledge of the product.Results: the healthcare facility reported the following sequence of events: a critically unwell patient with multiple comorbidities who had just undergone a lung lobectomy was admitted to the pacu in an unstable condition.The patient had desaturated to 70% spo2 and was provided with alternative oxygen therapy while an airvo 2 (device a) was being set up.The patient was placed on the airvo 2 which was initially set to 50l/min flow and 60% o2, however the patient's spo2 levels did not respond when placed on the airvo 2.In response, the o2 setting on airvo 2 was increased to100% and the flow rate of supplementary oxygen was increased to over 70l/min and the device generated an e192 error code.When an e192 error code is triggered, the airvo 2 continues to provide therapy.The device was replaced with another airvo 2 (device b) set to the same settings which generated the same error code.The patient was then intubated and moved to the icu for three days.It was later discovered that the patient had a complete lung collapse on the side that the lung lobectomy was performed.Visual inspection of both returned devices revealed no signs of impact damage to the outer enclosures of the devices.A review of the device logs of both devices confirmed that the e192 error code was logged.Performance testing of both the first airvo 2 device (device a) and second airvo 2 device (device b) confirmed that the devices were able to provide therapy, and the e192 error code could not be replicated when the flow rate of supplementary oxygen was within the maximum specification of 60l/min.During testing, the first airvo 2 device (device a) was found to have a noisy blower.The devices were opened for further investigation and evidence of water ingress was observed in first airvo 2 device (device a).There was no evidence of water ingress in the second airvo 2 (device b).Conclusion: we are unable to determine the exact cause of the reported event.An e192 error code occurs when there is noise detected in the oxygen readings of the sensor.It is likely that when supplementary oxygen is applied at high flow rates, the turbulence created when the device entrains the oxygen can trigger the e192 error code.This is supported by the healthcare facility's report that the e192 error code was generated when the supplied oxygen flow rate was increased to over 70l/min.This is higher than the maximum specified flow rate of 60l/min as per the airvo 2 user instructions.Additionally, the first airvo 2 device (device a) was found to have a noisy blower and evidence of water ingress was found when examining the device.Water ingress can cause a noisy blower.The acoustic vibrations generated by the noisy blower could have also created noise in the oxygen sensor readings and triggered the e192 error code.Water ingress can occur when the airvo 2 is tilted while the water chamber is in place.The healthcare facility reported that the patient was critically ill with multiple comorbidities and was later discovered to have suffered a complete lung collapse following a lung lobectomy that was performed prior to being admitted to the pacu.The healthcare facility further confirmed that the patient event was a result of patient and surgical factors.During the manufacturing process, quality control measures ensure each manufactured airvo 2 meets specification.The following specific controls ensure each device delivers flow as per the device performance specifications and that the unit is free from any physical damage: - visual examination: each unit is visually inspected for external damage and rejected if any damage is identified.- pressure flow testing: each unit is pressure tested and flow and oxygen measurements are verified to ensure there are no leaks in the airpath.- soak and reliability testing: each unit is connected to a hbt and water chamber, and then tested to ensure it performs as intended over extended operating conditions.These quality control measures are performed at the end of the final assembly process on 100% of the manufactured units.Any unit that fails any of these tests will be rejected.The subject devices would have met the required specifications.The airvo 2 humidifier user manual also states: -"airvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases" -"the unit is not intended for life support." -"do not connect supplementary oxygen to the airvo 2 at flow rates higher than the airvo 2 target flow rate, as excess oxygen will be vented into the surroundings, or 60l/min." -"the oxygen concentration delivered to the patient can be affected by changes to the flow setting, oxygen setting, patient interface or if the airpath is obstructed." -"do not store or use the unit where it can fall or be pulled into water.If water has entered the unit enclosure, disconnect the power cord and discontinue use." -"when handling the unit with the water chamber in place, avoid tilting the machine to prevent any chance of water entering the unit enclosure." -"empty all the water from the chamber before transporting the unit.".

Event Description

A healthcare facility in australia reported via a fisher & paykel healthcare (f&p) field representative that a sedated, non-responsive patient who had just had a lung lobectomy, was admitted to the post anaesthesia care unit (pacu) in an unstable condition.The patient had desaturated to 70% spo2 and was then provided with alternative oxygen therapy prior to being placed on a pt101 airvo 2 humidifier (airvo 2; sn (b)(6).The airvo 2 was initially set to50l/min flow and 60% o2; however, the patient's spo2 levels did not respond when placed on the airvo 2.In response, the o2 setting on the airvo 2 was increased to 100% and the flow rate of supplementary oxygen connected to the airvo 2 was increased to more than 70l/min upon which the device generated an e192 error code.The device was replaced with another airvo 2 (sn (b)(6) with the same settings.The airvo 2 immediately generated an e192 error code.The healthcare facility reported that the patient went into respiratory arrest and was intubated for three days in the intensive care unit (icu).The patient has since been extubated and transferred out of the icu into the ward, with no further consequences.Further information provided by the healthcare facility revealed that the patient had been critically unwell with multiple comorbidities prior to their admission to the pacu and had just undergone a lung lobectomy.It was later discovered by clinical staff after the incident that the patient had a complete lung collapse on the side that was operated on and had one lung functioning.The healthcare facility further confirmed that the patient event was a result of patient and surgical factors.

• 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
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534002
• MDR Report Key: 13993071
• MDR Text Key: 288471091
• Report Number: 9611451-2022-00313
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: REFER TO H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male