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

Model Number PT101

Device Problems Thermal Decomposition of Device (1071); Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of investigating the complaint device.We will provide a follow-up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, that a pt101 airvo 2 humidifier had fire damage.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Method: the complaint pt101 airvo 2 humidifier along with the power cord were returned to fisher & paykel healthcare (f&p) new zealand for evaluation where they were visually inspected and functionally tested by trained f&p personnel.Results: the visual inspection of the returned airvo 2 humidifier revealed no signs of impact damage.Power cord connector attached to the humidifier was observed melted.The airvo 2 humidifier was functionally tested with other f&p supplied airvo power cord and the device had no fault found.The airvo 2 performed as expected.Conclusion: the melted power cord connector returned along with the humidifier is qiaopu - qt8 power cord which is not the original power cord that f&p supplied to customer.Investigation confirmed that a poor connection wire to crimp inside the plastic connector caused heating and eventually melting the power cord connector.The user instructions that accompany the airvo 2 humidifier include the following warning: "never operate the unit if it has a damaged power cord or plug".Replacement of the mains plug on the power cord set of the airvo 2 humidifier is permitted, provided the person replacing the plug is qualified to do this as stipulated in the national electrical code (nec) of that particular eu region or country.

Event Description

A healthcare facility in germany reported, via a fisher & paykel healthcare (f&p) field representative, that a pt101 airvo 2 humidifier had fire damage.There was no reported patient consequence.

• 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: 9359836
• MDR Text Key: 174855704
• Report Number: 9611451-2019-01123
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422286
• UDI-Public: (01)09420012422286(10)2100036797(11)160331
• 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: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• 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: 2100036797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Date Manufacturer Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1