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

Model Number PT101

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/04/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Fisher and paykel healthcare (f&p) is in the process of retrieving further information and the subject pt101 airvo 2 humidifier.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via the medwatch reporting system that a pt101 airvo 2 humidifier had an oxygen flow issue.The healthcare facility reported that upon inspection it appeared that the airvo 2 humidifier had been dropped or that something had been dropped on the device.It was further reported that a small defect was found at the gas outlet.A covid-19 patient desaturated to 21% spo2 whilst using the subject airvo 2 humidifier, alternative therapy was provided with a non-rebreather mask and the patient recovered to 60% spo2.The patient was placed on bipap therapy and reached 88-92% spo2.The patient was later transferred to the intensive care unit and intubated.The patient later deceased of covid-19 10 days after the reported event.

Event Description

A healthcare facility in alabama reported via the medwatch reporting system that a pt101 airvo 2 humidifier (airvo 2) had an oxygen flow issue and that a small defect was found on the heated breathing tube (hbt) connection port (referred to as the "gas outlet").It was further reported, it appeared the unit had been dropped or that something was dropped onto it.A covid-19 patient desaturated to 21% spo2 whilst using the subject airvo 2, alternative therapy was provided with a non-rebreather mask and the patient recovered to 60% spo2.The patient was placed on bipap therapy and reached 88-92% spo2.Later that day, the patient was transferred to the intensive care unit (icu) and intubated.It was reported by the healthcare facility that the patient's condition in the icu continued to deteriorate.The patient passed away ten days after the reported event and the healthcare facility confirmed covid-19 as the cause of death.

Manufacturer Narrative

(b)(4).Method: the healthcare facility provided further information upon request, and the subject airvo 2 was returned to f&p new zealand for evaluation.An investigation was carried out by f&p new zealand which was based on the information provided by the healthcare facility, the evaluation of the subject airvo 2, and f&p's knowledge of the product.Results: the subject airvo 2 was visually inspected and physical damage to the hbt connection port was confirmed.It was noted that the damage did not prevent a hbt from connecting to the subject device.The subject device was performance tested as per the airvo 2 technical manual.Performance checks are carried out to verify the functions of the unit, the operation of the flow sensor and the audible alarm signal.A "check for leaks" test, "check for blockages" test and "check tube" test were completed as part of the performance checks and the subject airvo 2 passed all acceptance criteria.The device was also supplied with oxygen and tested at 60 l/min.The oxygen flow was manually adjusted and the device was confirmed to measure and display the full range of oxygen through the device, from 21% to 100%.In addition, the device was performance tested for an extended period of time and no error codes, alarms or leaks were detected during this period.The subject airvo 2 was found to be working as intended.No errors or faults were identified during the investigation and the reported event of no oxygen delivery could not be replicated.Overall, no fault was found with the subject airvo 2 device which could have caused or contributed to the reported event.The healthcare facility reported there was no oxygen delivery at the time of the desaturation event.However, it was also reported that the subject airvo 2 appeared to be functioning properly with no alarm conditions.Upon inspection of the device, the biomedical engineers at the healthcare facility reported that the hbt connection port of the airvo 2 was damaged, and that the damage was consistent with the device being dropped or something dropped on the device.The healthcare facility further reported that the covid-19 patient was placed on the airvo 2 after the patient had desaturated to 87% spo2.The customer also noted that the patient's condition was deteriorating due to the coronavirus disease and the patient deceased 10 days after the reported event, due to covid-19.Conclusion: evaluation of the subject airvo 2 confirmed the hbt outlet connector was damaged.This is consistent with the inspection performed by the healthcare facility where it was reported that the subject device appeared to have been dropped or something was dropped on it.The subject airvo 2 was investigated and tested, and was confirmed to be functioning as intended.Alarm conditions were also confirmed to be working as part of the performance checks.No errors or faults were found with the subject airvo 2 and the reported event of no oxygen delivery could not be replicated.The subject airvo 2 was confirmed to be working as intended.This is consistent with the information provided by the healthcare facility where they reported that the subject airvo 2 was inspected and appeared to be functioning properly; and that the patient's condition was deteriorating due to the coronavirus disease.Based on the investigation results and the information provided by the healthcare facility, f&p is unable to determine what has caused the reported event of no oxygen delivery.Furthermore, the healthcare facility reported that the patient passed away due to covid-19 and did not indicate that the reported event caused or contributed to the patient's death.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 device history record (dhr) for the subject airvo 2 (lot 2101366099; sn (b)(6); manufacturing date: 03 nov 2020) was reviewed.No non-conformances were noted on the dhr and it was confirmed that the device was manufactured according to specification and passed all the required quality control measures.The airvo 2 user manual states that the "airvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases" and "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply." the user manual also includes the following warnings: - the unit is not intended for life support.- appropriate patient monitoring must be used at all times.- never operate the unit if it is not working properly.- never operate the unit if it has been dropped or damaged.- never drop or insert any object into any opening or tube.

• 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 ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 13553734
• MDR Text Key: 285850843
• Report Number: 9611451-2022-00148
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422347
• UDI-Public: (01)09420012422347(10)2101366099(11)201103
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• 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: 2101366099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2020
• 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
• Treatment: PIPED OXYGEN.
• Patient Outcome(s): Other
• Patient Age: 52 YR