MAUDE Adverse Event Report: AIRVO 2 HUMIDIFIER

Model Number PT101

Device Problems Material Discolored (1170); Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint pt101 airvo 2 humidifier is currently en route to fisher & paykel healthcare (f&p) for evaluation to determine the involvement of our product in the reported event.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported on behalf of a distributor, via a fisher & paykel healthcare (f&p) field representative, that a flash of light was noticed near the air filter of a pt101 airvo 2 humidifier.The airvo 2 was removed from the oxygen source.5-10 minutes later it was noted that the back of the device was blackened.There was no patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint pt101 airvo 2 humidifier and the associated f&p power cord were returned to fisher & paykel healthcare for evaluation, where they were visually inspected and analysed.The f&p 900pt561 heated breathing tube (hbt) was not returned for investigation however, a photograph was provided and was visually inspected.Results: visual inspection of the complaint airvo 2 revealed that the filter, filter cover, plastic tube connecting the oxygen inlet, and the filter cover were found blackened.The complaint airvo 2 was opened for further inspection.The blower area showed blackened marks, however, was found to be in good condition.The oxygen sensor plastic filter was found melted and the oxygen sensor cover was found partially melted.The control and power pcb were tested and ran continuously without any errors.The blower pcb was also tested and had no short circuit.Review of the log file identified that the device was operational until approximately 1545 which aligns with timeline reported by the customer.Visual inspection of the returned power cord revealed a shallow burn mark closest to the filter end of the airvo 2.Further functional testing of the power cord revealed that it was in good condition and functioned normally.Visual inspection of the photograph of the 900pt561 hbt revealed that a section of the tubing was melted.The heater wires appeared to be intact as they were still attached to the remaining undamaged parts of the hbt.This evidence indicated that the hbt was not the likely source of ignition.The hospital noted that the hbt was not damaged prior to the incident and became damaged during the reported incident.Conclusion: based on our investigation, there was no indication that the source of ignition was from the airvo 2 unit or any f&p accessories.We were unable to determine the cause of the reported event.The results of our investigation and the information provided by the customer indicated that the event occurred due to the ignition of oxygen-rich gases close to the rear of the airvo 2 unit.There was no evidence to suggest that the airvo 2 unit itself or any f&p accessories were the source of ignition.This was supported by the functional state of all airvo 2 electronics inside the rear of the unit, and the condition these parts were found in.The airvo 2 humidifier is designed to the electrical safety standards, iec 60601-1 and can/csa-c22.2 no.60601-1.Our user instructions that accompany the pt101 airvo 2 humidifier state the following: "before using the airvo 2 with oxygen, read all of the following warnings: the use of oxygen requires that special care be taken to reduce the risk of fire.Accordingly, for safety it is necessary that all sources of ignition (e.G.Electrocautery or electrosurgery) be kept away from the unit and preferably out of the room in which it is being used.Oxygen should not be used while smoking or in the presence of an open flame.The unit should be located in a position where ventilation around the unit is not restricted.A spontaneous and violent ignition may occur if oil, grease or greasy substances come in contact with oxygen under pressure.These substances must be kept away from all oxygen equipment.Ensure that the airvo 2 is switched on before connecting oxygen.Do not connect supplementary oxygen to the airvo 2 at flow rates higher than the airvo 2 target flow rate, as excess oxygen will be vented into the surroundings, or 60l/min." our user instructions that accompany the 900pt561 heated breathing tube state the following: "never operate the unit if the breathing tube has been damaged with holes, tears or kinks." "do not use in the presence of a naked flame, to avoid fires." "do not add heat to any part of the breathing tube e.G.Covering with a blanket or heating it in an incubator or overhead heater for a neonate, as this could result in serious injury.".

Event Description

A healthcare facility in india reported on behalf of a distributor, via a fisher & paykel healthcare (f&p) field representative, that a flash of light was noticed near the air filter of a pt101 airvo 2 humidifier.The airvo 2 was removed from the oxygen source.5-10 minutes later it was noted that the back of the device was blackened.There was no patient consequence.

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: AIRVO 2 HUMIDIFIER
• MDR Report Key: 10723235
• MDR Text Key: 214556197
• Report Number: 9611451-2020-00924
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422354
• UDI-Public: (01)09420012422354(10)2100835495(11)190726
• Combination Product (y/n): N
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 2100835495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Initial Date Manufacturer Received: 09/28/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 03/07/2021
• Supplement Dates FDA Received: 03/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2019
• 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 900PT561 TUBE AND CHAMBER KIT.; F&P 900PT561 TUBE AND CHAMBER KIT.; F&P 900PT913 AIR FILTER.; F&P 900PT913 AIR FILTER.; F&P OPT944 OPTIFLOW ADULT NASAL CANNULA.; F&P OPT944 OPTIFLOW ADULT NASAL CANNULA.; OXYGEN INLET.; OXYGEN INLET.; THUSE ELEKTRONICS SMART PLUG.; THUSE ELEKTRONICS SMART PLUG.