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

Model Number PT101

Device Problem Sparking (2595)

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

Event Type  malfunction  

Event Description

A healthcare facility in france reported via a fisher and paykel healthcare (f&p) field representative that a pt101 airvo 2 humidifier generated a spark during patient use.It was noted that a black mark was observed on the power cord outlet of the device.There were no reported patient consequences.Further information regarding the reported event, including the sequence of events, was requested from the healthcare facility.

Manufacturer Narrative

(b)(4).The subject device is no longer in use by the healthcare facility.Fisher & paykel (f&p) has requested for the complaint device to be returned for evaluation.We will provide a follow up report upon completion of our investigation.Product background: the pt101 airvo 2 humidifier (airvo 2) device is an active humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.It's intended use is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.

Event Description

A healthcare facility in france reported via a fisher and paykel healthcare (f&p) field representative that a pt101 airvo 2 humidifier generated a spark during patient use, followed by a dim screen.As a result, there was a black mark on the power cord outlet of the device.There were no reported patient consequences.F&p requested further information about the event, however no response was provided.

Manufacturer Narrative

(b)(4).Product background: the pt101 airvo 2 humidifier (airvo 2) device is an active humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.It's intended use is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.The airvo 2 device should not be used for life support purposes, and appropriate patient monitoring must be used at all times.Method: the complaint airvo 2 device and power cord was received by fisher & paykel healthcare (f&p), where it was inspected by a trained f&p employee.Several attempts to request further information from the healthcare facility were made, including the sequence of events and device set-up.However, no response was provided.Our investigation is baed on the initial information provided by the healthcare facility, our evaluation of the subject device, previous investigations of similar complaintts, and our knowledge of the product.Results: visual inspection of the subject device's exterior revealed no signs of impact damage.However, visible marks were observed on the mains inlet socket cover of the device, confirming the reported event.Inspection of the subject power cord revealed that there was an open circuit along the positive wire in the lead.The subject airvo 2 was powered on using a known good power cord, and the airvo 2 device operated as intended, and had no issues with the device screen.Conclusion: we are unable to determine the cause of the reported event.However, based on previous investigations it is possible the damage to the internal wiring of the power cord may be caused by excessive bending force.Excessive bending force can cause the internal wiring to detach from the crimp, leading to a potential arcing (spark).All f&p airvo 2 humidifiers undergo inspection during the production.The reported airvo 2 device would have met the required specification at the time of production.Our user instructions which accompany the pt101 airvo 2 humidifier state the following: avoid unncessary removal of the power cord from the rear of the device.Avoid pulling on the power cord.Appropriate patient monitoring must be used at all times.

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: RESPIRATORY 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: omid taheri ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 8007923912
• MDR Report Key: 17770437
• MDR Text Key: 324230435
• Report Number: 9611451-2023-00868
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422286
• UDI-Public: (01)09420012422286(10)2100344578(11)171030
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/21/2023

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: 2100344578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2023
• Initial Date FDA Received: 09/18/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2017
• 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