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

Model Number PT101

Device Problems Loss of Power (1475); Unexpected Shutdown (4019)

Patient Problem Death (1802)

Event Date 09/12/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).We are in the process of obtaining further information and the involved device for investigation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) alleged that a patient died while using a pt101 airvo2 humidifier after the device "switched off by itself" during treatment.The hospital confirmed that the patient was in a poor state of health just prior to the incident.It was reported that the patient had a fibrosis a few days before the incident and as a result had been recently moved from the rehabilitation and recuperative care department to the pneumology department where he was then treated on airvo2 humidifier.It was in the pneumology department that the incident occurred.Following the report of the incident, a fisher & paykel healthcare (f&p) field representative in (b)(6) contacted the healthcare facility to obtain further information about the reported event.We have also contacted the facility via email for further details, however, incomplete information was received and we are still awaiting more information.Based on information provided, f&p has not yet established a correlation between the reported event and the patient's death.

Event Description

A healthcare facility in france alleged that a patient died whilst using a pt101 airvo2 humidifier after the device "switched off" by itself during treatment.The hospital confirmed that the patient was in a poor state of health just before the incident.It was reported that the patient had a fibrosis a few days before the incident and as a result had been recently moved from the rehabilitation and recuperative care department to the pneumolgy department where he was then treated on airvo2 device.It was in the pneumology department where the incident occurred.

Manufacturer Narrative

(b)(4).Additional information was requested from the customer as part of the root cause analysis.The customer provided additional information regarding the patient's medical history relevant to this event: the patient had "very severe chronic obstructive pulmonary disease (copd)", "lobectomy operated lung cancer" (part of his lung was surgically removed due to cancer), "chronic respiratory failure", "a recent pleural effusion" (excess fluid buildup around outside of lungs, which can make it harder for the lung to expand) and "suspicion of cordarone (antiarrhythmic medication) pneumopathy".Medications and con-commitment therapies given to the patient during this event: rosuvastatin (statin - cardiovascular), lansoprazole (reduces production of stomach acid), urorec (treatment of benign prostatic hyperplasia), inorial (antiallergic agent), paracetamol (pain relief medication), nebivolol (treatment for hypertension and heart failure), alprazolam (treatment for anxiety disorders), abasaglar, novorapide (treament for diabetes), enoxaparine(anticoagulant).The patient also had a 'do-not-resuscitate (dnr)' order, which is a medical order written by a doctor to instruct health care providers not to do cardiopulmonary resuscitation (cpr) if a patient's breathing stops or if the patient's heart stops beating.Fisher & paykel healthcare's (f&p) clinical assessment of the information provided by the hospital regarding the patient's existing medical conditions related to this event, revealed that the patient presented with severe respiratory failure.The hospital also confirmed that "the patient was in a poor state of health just before the incident".It was further reported that the hospital staff finished cleaning and toileting the patient, before noticing that the airvo 2 humidifier was not switched on.The patient had 'dnr' orders in place.The hospital reported that "the patient ultimately died, which was expected".Further information regarding the device set-up and the patient's care were requested from the customer, however, no further information was received.Method: the complaint pt101 airvo 2 humidifier was received at f&p new zealand for investigation.The unit was visually inspected for defects and functionally tested for an extended period.Results: during testing, the airvo 2 humidifier powered on and the blower was found to be fully functioning.The reported malfunction of the airvo 2 humidifier "switched off by itself" could not be confirmed.During the inspection, it was revealed that the audio alarm of the complaint airvo 2 humidifier was not working which is caused by a faulty speaker and electrical resistance testing has shown the speaker's resistance to being open circuit.However, no fault was found which could cause the unit to switch off during use.An analysis of the device log provides basic information regarding the set-up of the airvo 2 humidifier.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.A review of the log identified that the check water alarm occurred and was successfully resolved by the user.The log identified that the power was removed from the airvo 2 humidifier at approximately 09:51 am which is consistent with the events reported by the hospital.Conclusion: we are unable to determine what caused the reported event as the device was able to be powered on and capable of delivering therapy.Based on the device analysis, additional information provided by the customer and our knowledge of the product the most likely cause of the airvo 2 humidifier switching off was due to a disruption of the power source to the airvo 2 humidifier.The pt101 airvo2 humidifier user manual states that the "airvo is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases" and "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply".Additionally, the user manual also warns the user: - the unit is not intended for life support.- appropriate patient monitoring must be used at all times.Loss of therapy will occur if power is lost.

• 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
• MDR Report Key: 9177736
• MDR Text Key: 161935112
• Report Number: 9611451-2019-00950
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/13/2019

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: 150706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 10/10/2019
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 87 YR