MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AIRVO2 HUMIDIFIER

Model Number PT101

Device Problems Loss of Power (1475); Electrical Power Problem (2925)

Patient Problem Death (1802)

Event Date 07/18/2014

Event Type  Death  

Event Description

A healthcare facility in (b)(6) reported that a (b)(6) patient had died on (b)(6) 2014.The patient was on rotation between two pt100 airvo humidifiers at eight hourly intervals.The airvo units were reported to have shut down after about 8-12 hours of continuous use but turned on fine after leaving them off for a while.The airvo humidifiers were first used on (b)(6) 2014 and after eight hours the problem occurred.The patient was on the airvo unit non-stop in the home setting.It was further reported that an electrician measured the voltage of the house to be about 122 volts and that the area is known to have a higher wall voltage.The patient was subsequently re-admitted to hospital (hospice) and died while there.

Manufacturer Narrative

(b)(4).We have not been informed (despite requests) of the cause of death of the infant.However, to date we have not received any information that indicates that the airvos caused or contributed to the infant's death.The patient was not using the airvo at the time of death but had left the home and was back in hospice care.The parents of the patient had commented that there were power issues in the home and that the lights tended to flicker on and off a lot.Fisher & paykel healthcare has requested the return of the two airvo humidifiers in order to evaluate them.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in indiana reported that a (b)(6) patient had died on (b)(6) 2014.The patient was on rotation between two pt100 airvo humidifiers at eight hourly intervals.The airvo units were reported to have shut down after about 8-12 hours of continuous use but turned on fine after leaving them off for a while.The airvo humdifiers were first used on(b)(6) 2014 and after eight hours the problem occurred.The patient was on the airvo unit non-stop in the home setting.It was further reported that an electrician measured the voltage of the house to be about 122 volts and that the area is known to have a higher wall voltage.The patient was subsequently re-admitted to hospital (hospice) and died while there.

Manufacturer Narrative

(b)(4).Method: when this incident was reported to us, further information was sought from the reporter.We were informed that the patient was admitted to a hospice and died there, and that no direct connection had not been established between the patient's death and use of the airvo.We were also informed that pulse oximetry was being used to monitor the patient's blood-oxygen saturation, which is in line with our user instructions.Both of the complaint airvo humidifiers were received at fisher & paykel healthcare new zealand.Devices (b)(4).Both devices were manufactured on 17 april 2013.The complaint airvos were visually inspected and performance tested.Results: device 1: the airvo¿ tube was attached to the unit and a normal cycle was started.Power was applied and the unit was turned on and operated, and shortly after displayed an 'oxygen too high' alarm.The unit was opened for further inspection and the fault was traced to a faulty sensor.Device 2: the airvo settings were adjusted to match the settings used to treat the patient and test run for 12 hours, during which time it did not shut off or display any errors.The unit was also tested at 122 volts for 27 hours and during this time no power out issues arose.Conclusion: device 1 had an oxygen sensor fault.This would have caused the airvo to display an alarm, but would not have affected the therapy being delivered to the patient.Device 2 operated correctly during testing and did not shut down at any time.While we were not informed of the cause of death we have been told that the patient had congenital heart and lung defects so severe that ecmo treatment was required to keep the patient alive during the first month of life.There is no evidence to suggest that the airvo units caused or contributed to the death of the patient.The airvo 2 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." our user instructions that accompany the airvo humidifier state that "the airvo 2 is for the treatment of spontaneously breathing patients (adult and pediatric > 3 kg) who would benefit from receiving high flow warmed and humidified respiratory gases." they also state: "the unit is not intended for life support.".

• 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
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 4043405
• MDR Text Key: 15180777
• Report Number: 9611451-2014-00735
• Device Sequence Number: 1
• Product Code: BTT
• 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: Consumer,Health Professional,User Facility
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• 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: 130417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: FISHER & PAYKEL OPT316 OPTIFLOW JUNIOR CANNULA; FISHER & PAYKEL OPT316 OPTIFLOW JUNIOR CANNULA
• Patient Outcome(s): Congenital Anomaly; Death; Hospitalization
• Patient Age: 4 MO