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

Model Number PT100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 12/05/2019

Event Type  Death  

Manufacturer Narrative

Ps328074.The complaint pt100 myairvo humidifier is currently en route to fisher & paykel healthcare (f&p) in new zealand for evaluation to determine if f&p's device caused or contributed to the reported event.We are also in the process of obtaining further information from the customer.We will provide a follow up report upon completion of the investigation.

Event Description

A hospital in the (b)(6) reported that a home patient had died whilst on an pt100 myairvo humidifier (myairvo) with an oxygen concentrator.There was no reported malfunction of the myairvo.It was reported that the oxygen concentrator was showing "back pressure alarm".The patient was suffering from interstitial lung disease (ild) and was prescribed variable oxygen therapy.

Event Description

A hospital in the uk reported that a home patient had died whilst on an pt100 myairvo humidifier (myairvo) with an oxygen concentrator.There was no reported malfunction of the myairvo.It was reported that the oxygen concentrator was showing "back pressure alarm".The patient was suffering from interstitial lung disease (ild) and was prescribed variable oxygen therapy.

Manufacturer Narrative

Ps328074 method: the complaint pt100 myairvo humidifier was returned to fisher & paykel healthcare (f&p) in new zealand for evaluation and was visually inspected and functionally tested.The log report retrieved from the complaint myairvo was reviewed.Results: visual inspection showed no signs of impact damage including to the oxygen extension kit and the air filter on the myairvo.The device was tested by running for a prolonged period of time and no error code was generated.The review of the log report revealed that there was no warning logged on the event date which is on (b)(6)2019.Conclusion: we are unable to determine what has caused the "back pressure alarm" on the oxygen concentrator as there was no fault found with the subject myairvo device.The myairvo user manual states that the "myairvo 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".The myairvo user manual also states following warning: 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.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.If either alarm signal is absent, do not use the unit.Contact your fisher & paykel healthcare representative.

• Brand Name: MYAIRVO HUMIDIFIER
• Type of Device: MYAIRVO HUMIDIFIER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 9541203
• MDR Text Key: 173445668
• Report Number: 9611451-2020-00003
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422255
• UDI-Public: (01)09420012422255(10)2100331280(11)171012
• 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: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PT100
• Device Catalogue Number: PT100
• Device Lot Number: 2100331280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VIVISOL DOLBY PLATINUM 9 OXYGEN CONCENTRATOR; VIVISOL DOLBY PLATINUM 9 OXYGEN CONCENTRATOR
• Patient Outcome(s): Death