MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD BI-LEVEL / CPAP SINGLE LIMB CIRCUIT KIT (WITH FILTER); BTT

Model Number 950A61

Device Problem Melted (1385)

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

Event Date 02/23/2024

Event Type  malfunction  

Event Description

A healthcare facility in australia reported via a fisher & paykel healthcare (f&p) field representative, that the inspiratory limb of a f&p 950a61 adult bi-level / cpap heated circuit kit (with filter) was found melted onto the patients' bedsheets.The healthcare facility also reported after removing the complaint circuit and 950 respiratory humidifier device from the room, a burning smell was evident when the device was plugged back in.The healthcare facility further reported that the device was in use for 32 minutes.There was no patient consequence.

Manufacturer Narrative

(b)(4).Section g4 pma/510(k) number: the 950a61 adult bi-level / cpap heated circuit kit (with filter) is not sold in the united states of america (usa), but instead a similar product 950a61j adult bi-level / cpap heated circuit kit (with filter) is sold in the usa.Therefore, the 510(k) number for 950a61j adult bi-level / cpap heated circuit kit (with filter) has been used under the section g4.Fisher & paykel healthcare (f&p) is currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.

• Brand Name: BI-LEVEL / CPAP SINGLE LIMB CIRCUIT KIT (WITH FILTER)
• Type of Device: BTT
• 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: 18975564
• MDR Text Key: 338677064
• Report Number: 9611451-2024-00204
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K220703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 950A61
• Device Catalogue Number: 950A61
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1