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

Model Number PT101

Device Problem Device Operational Issue (2914)

Patient Problems Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 05/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Fisher and paykel healthcare is still seeking further information and arranging for the return of the complaint devices.We will provide a final report upon completion of our investigation.

Event Description

A hospital in turkey reported that an eight and a half month old patient was on a setup which included a pt101 airvo2 humidifier when a fire started in the system.The patient received injuries to the right side of the head and neck.The doctor reported that there were first and second degree burnt areas and that they immediately started treatment for the injuries.

Manufacturer Narrative

(b)(4).Following receipt of this complaint, on (b)(4) 2017, fisher & paykel healthcare (fph) representatives from our (b)(6) regional office and from our (b)(4) head office visited the hospital to begin an investigation.Our investigations team interviewed staff who were present during the incident.During these interviews, staff commented that they observed that the heated breathing tube (hbt) tubing was 'bent' prior to being placed on the patient.With regard to the patient status, the doctor in charge stated that it was unlikely that the infant would sustain scarring as a result of the incident.It has since been confirmed by the hospital that the infant has fully recovered from the injuries sustained during the incident.Investigation conducted at fph (b)(4): the following devices were received for investigation: pt101 airvo humidifier, sn (b)(4): the device had soot marks on the front of the casing.The finger guard had a melted portion of what looked like bedding material adhering to it.Mr290 chamber, lot 161019: the chamber had soot marks on the front of the dome and a melted portion of what looked like bedding material adhering to it.(b)(4) heated breathing tube, lot 160916.About 80mm was missing from the patient end of the tubing and the proximal end was burnt and blackened.The remaining tubing was kinked along its length in a number of places.(b)(4) junior cannula, lot unknown: both the tubing and the cannula were broken and burnt.Other items present on the bedding at the time of the incident, including blankets, sheets and non-fph monitoring equipment.Some of these had soot and scorch marks.Testing of the complaint airvo humidifier: the airvo was run for one week on a test bench at fisher & paykel healthcare without any faults.The airvo was found to warm up and stabilise in an acceptable time.The airvo was found to respond appropriately to common user errors such as missing tube and no water in the chamber.The oxygen and flow sensors were tested and found to be within stated accuracy across their specified ranges.Pressure testing of the airvo found no leaks.No fault was found with the returned airvo.Testing of the complaint (b)(4) hbt: background: the corrugated tube in the airvo hbt is extruded using a linear low density polyethylene (lldpe).The material has a characteristic melting peak depending on its heat history.During the extrusion process the rate of cooling produces a single melting peak which starts at 96° celsius and ends at 123°c with a maximum point at 113°c when examined using a differential scanning calorimeter (dsc).Testing of production sample hbts as well as used hbts confirmed that all airvo hbts have the same single melting peak heat signature.Testing: the complaint hbt was tested using dsc.Multiple small samples were taken from this tube along its length.All of these samples showed double melting peaks and differed significantly from the normal airvo hbt.Replication of the 'bent' tubing: measures were taken to replicate the kinking observed in the hbt involved in the incident.Specific features of interest were: permanent bends and kinks in the tubing along its length.Characteristic double melting peaks as shown in differential scanning calorimetry.The only method by which we were able to replicate the observed kinking of the hbt tube was by placing an hbt in a medical washer/ disinfection machine.In this machine the tubing is folded and placed into a basket within the machine.The machine then washes the tubing at temperatures of up to 98°c.This is then followed by a drying cycle which dries at temperatures of up to 135°c.The characteristic kinks along the tube and double melting peaks were replicated by this process.Conclusion: the airvo functioned correctly when tested.No malfunction of the airvo occurred.The double melting peaks of the complaint hbt demonstrate that the tube has been exposed to a temperature just below the melting point peak of 113°c and cooled at a slower rate than the production tube and this has allowed the crystalline structure to develop two distinct zones which correspond to the bimodal molecular distribution of the lldpe.This phenomenon cannot be explained by the fire which occurred at the time of the incident because many of the samples taken from the tubing were distant from the fire event.Hospital staff have confirmed that the hbt was kinked and bent when they first placed it on the patient.Our testing has demonstrated that this kinking is the result of the hbt being subjected to uniform heat of around 100°c.This suggests that the hbt was folded and placed in a disinfection unit and that the heat damage and kinking occurred at this time.Such heat damage would compromise the functionality of the hbt and render it unsuitable for use.The airvo complies with the electrical safety standard iec 60601-1 and also with the electromagnetic compatibility requirements of (b)(4).The airvo user manual states:"never operate the unit if the heated breathing tube has been damaged with holes, tears or kinks" and also contains the following warning: "to avoid burns: · do not modify the breathing tube or interface in any way." our user instructions which accompany the (b)(4) junior tubing kit state: do not wash, soak or sterilise.

Event Description

A hospital in (b)(6) reported that an (b)(6) old patient was on a setup which included a pt101 airvo2 humidifier when a fire started in the system.It was reported that the patient received injuries to the right side of the head and neck.The doctor reported that there were first and second degree burnt areas and that they immediately started treatment for the injuries.

• 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: sharon kuruvilla ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6628968
• MDR Text Key: 77218504
• Report Number: 9611451-2017-00517
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 2100110519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2017
• Initial Date FDA Received: 06/08/2017
• Supplement Dates Manufacturer Received: 05/12/2017
• Supplement Dates FDA Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2016
• 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: 8.5 MO