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

Model Number PT101

Device Problem Fire (1245)

Patient Problems Death (1802); Partial thickness (Second Degree) Burn (2694); Cancer (3262)

Event Date 01/11/2015

Event Type  Injury  

Event Description

A hospital in (b)(6) reported that after four days of use with an airvo 2 humidifier and an opt844 adult nasal cannula, there was a fire on (b)(6) 2015 at around 1:20 am.The mask, cannula, end of breathing tube and patient gown was burnt.The patient also sustained burns to the nose and chest.Two people with the patient at the time alerted the nurse and the fire was extinguished using a blanket.The patient sustained second degree burns (blisters) to the face and chest.The patient died about 31 hours later on (b)(6) 2015 at 8:30 am.The patient was terminally ill with cancer, and with an estimated two to three days left to live.

Manufacturer Narrative

(b)(4).Immediately following the report of this incident, representatives from fisher & paykel visited the hospital to seek further information.We were informed that the patient was a terminally ill cancer patient (estimated 2-3 days left to live), with difficulty of breathing (and breathing through mouth) and very low spo2 dropping rapidly.The hospital put the patient on an airvo with a cannula, at 95% oxygen and 40 litres of flow.The patient was breathing through his mouth and spo2 dropped so they applied an o2 mask on top of the cannula.After four days of high flow therapy on (b)(6) 2015 around 1:20 am, there was a fire and the mask, cannula, end of breathing tube and patient gown was burnt.The patient's nose and chest was also burnt.There were two people (visitors) with the patient at the time who alerted the nurse.According to the nurse, she covered the patient interface with a blanket and removed it from the patient.The cannula, mask, blanket and patient gown were immediately disposed of by the hospital and were thus not available for evaluation.There is no cctv in the hospital ward.The patient was pronounced dead on (b)(6) 2015.An autopsy was not carried out to confirm cause of death, at the insistence of the family.The (b)(6) police removed the subject airvo humidifier and breathing tube and passed it to (b)(6).At this stage it is not clear when or if we will be able to obtain the devices for evaluation.Photographs were obtained of the complaint airvo and heated breathing tube.The photographs show that there is no visible damage to the airvo.The patient end connector and a few centimetres of tube is melted and charred and the rest of the heated breathing tube appears undamaged.The two witnesses present during the incident have not provided any information regarding how the fire started and there was no hospital staff member present in the ward leading up to the time of the fire.It is thus not clear what the source of the ignition was.(b)(4).During production the heater wires are 100% visually inspected using a (b)(4).The heater wires are also tested for resistance, continuity, polarity and pitch during production.Before the product leaves the line a full functional test is conducted under load.Based on the limited event information we have at this stage, and in the absence of any devices or components to evaluate, we are unable to determine how the fire started.Our knowledge of the airvo and its functions would suggest that it was not the source of ignition.The minor nature of the burns sustained to the patient's face are not consistent with a device on fire and 40 litres of low with 95% oxygen.Rather it is likely that there was an external ignition source.We have not received any other reports for the airvo related to fire.If we obtain the complaint devices or receive further information we will provide a follow up report at that time.

• 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: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 4498536
• MDR Text Key: 16556341
• Report Number: 9611451-2015-00067
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2015
• 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: 140422
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/22/2014
• 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 OPT844 NASAL CANNULA
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 52 YR