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

Model Number PT101

Device Problems Device Alarm System (1012); No Audible Alarm (1019); Loss of Power (1475); Unexpected Shutdown (4019)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare (f&p) is currently in the process of retrieving further information and the subject (b)(4) airvo 2 humidifier for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in the (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a patient desaturated to 90% spo2 when a (b)(4) airvo 2 humidifier shut down during a routine power outage.The patient was provided alternative therapy whilst the subject airvo 2 unit was restarted.The airvo 2 unit generated a persistent "check environmental conditions" alarm.The patient desaturated to 87% spo2 and was provided alternative oxygen therapy whilst the airvo 2 unit was replaced.The patient recovered to a stable condition.It was further reported that the subject airvo 2 had no audible alarm.There were no further patient consequences.

Event Description

A healthcare facility in the united kingdom reported via a fisher & paykel healthcare (f&p) field representative that a patient desaturated to 90% spo2 when a pt101 airvo 2 humidifier shut down during a routine power outage.The patient quickly received alternative oxygen therapy until being placed back onto the subject pt101 unit.It was further reported that the pt101 unit alarmed twice to "check environmental conditions" and was troubleshooted.The pt101 unit displayed the alarm a third time whilst the patient was being transferred to the intensive care unit (icu) to be given a different pt101 airvo 2 humidifier.Staff discovered that the patient desaturated to spo2 87% and the patient was provided alternative oxygen therapy until being placed onto a different airvo 2 unit.The patient recovered to a stable condition.It was further reported that there was no audible alarm.There were no further patient consequences.

Manufacturer Narrative

(b)(4) method: the complaint pt101 airvo 2 humidifier was returned to fisher & paykel healthcare (f&p) where it was visually inspected and analysed.Results: the customer reported that a routine power outage occurred at approximately 9am,(b)(6) 2021, after which the device repeatedly displayed 'check operating conditions', with no audible alarm.Visual inspection of the returned device revealed no signs of external damage.A review of the log identified that e183 error code was triggered around the time of the reported event.The unit was performance tested, confirming that there was no audible alarm.Previous investigations into audio alarm failures have identified that the problem is caused by a faulty speaker and electrical resistance testing has shown the speaker's resistance to be open circuit.The unit was opened for further inspection and no other fault was found.An e183 error code occurs when there is a fault detected in the measurement of oxygen flow.Should this occur, the device continues to provide therapy and will generate an audible and visual alarm displaying 'check operating conditions' and 'switch off the unit and then restart'.Conclusion: a routine power outage at the hospital disrupted the power source of the pt101 airvo 2 humidifier and the device shut down.Once restarted, it began generating an e183 error message to 'check operating conditions'.We are unable to determine the cause of the e183 error message as this was not replicated during our performance test.The airvo 2 is designed to work with a power supply.If the power is disconnected from the airvo 2, a power out alarm occurs for at least 120 seconds to alert the user/caregiver.As part of our ongoing product improvement initiatives, a new speaker unit has been sourced from a different supplier.There was no other fault found with the subject device.It should be noted that the subject device is over five years old.The airvo 2 user manual states that the "airvo 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases" and that "the unit is not intended for life support." the user manual warns the user: - 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 muse be used at all times.Loss of therapy will occur if power is lost.- use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply.The alarm system functionality check instructs the user on how to check the alarm and states that "if either alarm signal is absent, do not use the unit.Contact your fisher & paykel healthcare representative.".

• 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: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 12756478
• MDR Text Key: 285559162
• Report Number: 9611451-2021-01192
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422354
• UDI-Public: (01)09420012422354(10)2100015174(11)151221
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

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: 2100015174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 12/23/2021
• Supplement Dates FDA Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2015
• 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 HEATED BREATHING TUBE AND CHAMBER KIT.; F&P OPT316 OPTIFLOW JUNIOR NASAL CANNULA.