MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD MYAIRVO 2 HUMIDIFIER; RESPIRATORY HUMIDIFIER

Model Number PT100

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

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/30/2023

Event Type  Injury  

Event Description

On 20 july 2023 a distributor in italy reported via a fisher & paykel healthcare (f&p) field representative that on (b)(6) 2023 a patient was discharged from hospital and started using a pt100 myairvo 2 humidifier (myairvo 2).The distributor reported that on (b)(6) 2023 the patient desaturated and was readmitted to hospital.The distributor also reported that on (b)(6) 2023 the patient was still hospitalised and had a saturation above 95% spo2.It was also reported by the distributor that the hospital inspected the myairvo 2 and found a fault with the subject device.The fault with the subject myairvo 2 was not specified by the distributor.F&p have requested further information about the reported event, including information about the patient condition, sequence of events and the reported fault with the subject myairvo 2.

Manufacturer Narrative

Ps427659 fisher & paykel healthcare (f&p) have requested that the subject device be returned for investigation.F&p have also requested further information about the reported event, including information about the patient condition, sequence of events and the reported fault with the subject pt100 myairvo 2 humidifier (myairvo 2).F&p will provide a follow up report upon completion of our investigation.Product background: the myairvo 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.It's intended use is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The myairvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.

Manufacturer Narrative

(b)(4).Product background: the myairvo 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.It's intended use is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The myairvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.Method: the subject myairvo 2 was received at fisher & paykel healthcare (f&p) in new zealand where it was inspected, and performance tested by a trained f&p technician.Our investigation is based on the information provided by the customer, our evaluation of the subject device and our knowledge of the product.Results: it was reported by the distributor that the patient, who had been discharged from hospital the previous day, had desaturated to 47-48% spo2 before being readmitted to hospital with a 37% spo2.The patient was placed on a new device and recovered.There were no further patient consequences reported, however the patient remained hospitalised following the event.It was reported that the patient was using the subject myairvo 2 at home with supplemental oxygen and had been provided instructions through technicians at the distributor.The distributor reported that following the event the hospital "noticed the subject myairvo 2 had a malfunction because when the patient was placed on the hospital device with the same settings, the patient recovered." it was reported that the device did not generate any alarms at the time of event.No further information regarding the subject device was provided by the hospital.Visual inspection of the returned myairvo 2 revealed no signs of damage to the device.The device was powered on and the device's display and audible alarm were found to be operating as expected.A review of the device log showed no recorded errors at the time of the reported event.The device was tested by running for multiple hours with no fault found.The device was opened for further investigation and all internal components were found to be in good condition.Conclusion: we cannot identify that the subject device caused or contributed to the reported event as the information provided from the hospital and distributor did not specify the device malfunction and our investigation found no fault with the returned device.During the manufacturing process, quality control measures ensure each manufactured myairvo 2 meets specification.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 device would have met the required specifications.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 to ensure there are no leaks in the airpath.Flow and oxygen sensors are calibrated and checked for accuracy.- 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.The myairvo 2 user instructions state the following: - "appropriate patient monitoring must be used at all times." - "the unit is not intended for life support." - "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply." - "check that suitable blood saturation levels are achieved at the prescribed flow." - "it is important that the physician prescribing your oxygen therapy approves both the flow and oxygen settings and you do not adjust these prescribed settings without consulting them." - "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.".

Event Description

On (b)(6) 2023 a distributor in italy reported via a fisher & paykel healthcare (f&p) field representative that on (b)(6) 2023 a patient was discharged from hospital and started using a pt100 myairvo 2 humidifier (myairvo 2) with supplemental oxygen and a myopt9medium nasal cannula.The distributor reported that on (b)(6) 2023 the patient desaturated and was readmitted to hospital.Further information was requested from the distributor and it was reported that the patient desaturated to 47-48% spo2 at the time of the event and when the patient arrived in hospital had further desaturated to 37% spo2.It was reported that in hospital the patient was placed on another device with the same settings and that the patient's spo2 increased.The distributor reported that on (b)(6) 2023 the patient was still hospitalised and had a saturation above 95% spo2.There were no other patient consequences reported.It was also reported by the distributor that the hospital identified a malfunction with the subject device.When further information about the malfunction was requested the distributor reported that "the hospital noticed the subject myairvo 2 had a malfunction because when the patient was placed on the hospital device with the same settings, the patient recovered." no further information about the subject device was provided and the hospital confirmed that the device did not generate any alarms.

• Brand Name: MYAIRVO 2 HUMIDIFIER
• Type of Device: RESPIRATORY 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17561701
• MDR Text Key: 321310989
• Report Number: 9611451-2023-00757
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422194
• UDI-Public: (01)09420012422194(10)2101422909(11)201205
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PT100
• Device Catalogue Number: PT100
• Device Lot Number: 2101422909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2020
• 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: F&P MYOPT9MEDIUM OPTIFLOW + ADULT NASAL CANNULA
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR