MAUDE Adverse Event Report: AIRVO 2 HUMIDIFIER

Model Number PT101

Device Problem Fire (1245)

Patient Problem Burn(s) (1757)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint pt101 airvo 2 humidifier is expected, but has not yet been returned to f&p to determine if it caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

The (b)(6) reported that a pt101 airvo 2 humidifier was involved in a fire.It was later reported via a fisher & paykel healthcare (f&p) field representative that the event occurred while in use on a patient and the patient suffered minor burns to the upper part of their legs and stomach.The nurse detached the patient from the device and evacuated the patient from the room.A cold compress was applied to the patient's burns.It was further reported that the patient was later transferred to another hospital, however this was unrelated to the reported incident.

Manufacturer Narrative

(b)(4).Method: f&p healthcare contacted the customer, ((b)(6) hospital), to obtain further information on the reported event and to request the return of the subject airvo 2 humidifier.We have made multiple attempts to follow up with the customer, however limited information was provided.The following complaint devices were returned to fisher & paykel healthcare new zealand (f&p) for investigation; airvo 2 respiratory humidifier, 900pt561 heated breathing tube and water chamber, 900pt401 water bag, power cord and some parts of the opt944 optiflow + nasal cannula were also received.An investigation has been undertaken to determine the root cause of the reported event.The investigation included the inspection and testing of the returned complaint devices and a review of the manufacturing report of the subject airvo 2 device.Results: the manufacturing report (dhr) of the subject airvo 2 was reviewed which indicated that the device passed all production tests, including an electrical safety test (est), airvo functional test (aft), soak and visual test.There were no non-conformances identified in the manufacturing report.The returned sub-components of the airvo 2 (power cord, oxygen module, chamber outlet elbow thermistors, control pcb, power pcb, heater plate, blower module, and the hbt connection to airvo 2) were visually inspected, electrically tested for continuity and performance tested.Components that were still intact (i.E.Not damaged from the fire) were subjected to electrical testing and were found to be functioning as intended.The components that were found damaged and could not be electrically tested were low power components and therefore were not a possible source of ignition.As such, the sub-components of the airvo 2 were not considered as possible sources of ignition in this event.The remains of the cannula were returned to f&p for investigation.The inside surfaces were swabbed, and no evidence of open fire or flames were found.There were no internal ignition sources present in the cannula.The remains of the hbt were visually inspected and tested.The returned parts of the hbt were tested and passed electrical continuity tests.The electrical connections between the hbt and the airvo 2 were tested and passed electrical continuity tests.The inside surfaces of the tube were swabbed, in several places and a small amount of soot was found.This is indicative of smoke traveling along and being deposited inside the tube but is not consistent with fire travelling along inside the tube.Therefore, the hbt and cannula are not considered as possible sources of ignition.The airvo 2 device compliance log provides basic information regarding the set-up of the airvo 2.The airvo 2 log showed that the device was set to default (adult) mode which is the correct mode for the patient based on the information provided by the customer.The log did not identify a potential cause of the ignition.Conclusion: the cause of the reported event could not be determined.No source of ignition was found within the airvo 2 or its accessories.The airvo 2 user manual states warnings: - before using the airvo 2 with oxygen, read all of the following warnings: - the use of oxygen requires that special care is taken to reduce the risk of fire.Accordingly, for safety it is necessary that all sources of ignition (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.Prior to each patient use, ensure that the auditory alarm signal is audible by conducting the alarm system functionality check described in the alarms section.Appropriate patient monitoring must be used at all times.The airspiral heated breathing tube user instruction states: 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.The optiflow + nasal cannula user instruction states: do not use near a naked flame, to avoid fires.

Event Description

The ministry of health in turkey reported that a pt101 airvo 2 humidifier was involved in a fire.There was no report of a malfunction.It was later reported via a fisher & paykel healthcare (f&p) field representative that the event occurred while in use on a patient and the patient suffered minor burns to the upper part of their legs and stomach.The nurse detached the patient from the device and evacuated the patient from the room.A cold compress was applied to the patient's burns.It was further reported that the patient was later transferred to another hospital, however this was unrelated to the reported incident.

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: AIRVO 2 HUMIDIFIER
• MDR Report Key: 11137012
• MDR Text Key: 227016596
• Report Number: 9611451-2020-01197
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422309
• UDI-Public: (01)09420012422309(10)2101268420(11)200901
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• 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: 2101268420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2021
• Date Manufacturer Received: 06/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2020
• 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 900PT405 AIRVO 2 HUMIDIFIER POLE MOUNTING TRAY; F&P 900PT405 AIRVO 2 HUMIDIFIER POLE MOUNTING TRAY; F&P 900PT421 AIRVO MOBILE POLE STAND; F&P 900PT421 AIRVO MOBILE POLE STAND; F&P 900PT561 BREATHING TUBE AND CHAMBER; F&P 900PT561 BREATHING TUBE AND CHAMBER; F&P OPT944 OPTIFLOW NASAL CANNULA; F&P OPT944 OPTIFLOW NASAL CANNULA; MEDSPA PATIENT BED; MEDSPA PATIENT BED; MEDWARM PATIENT WARMING SYSTEM (BLANKET); MEDWARM PATIENT WARMING SYSTEM (BLANKET); MINDRAT BENEVIEW T8 PATIENT MONITOR; MINDRAT BENEVIEW T8 PATIENT MONITOR