MAUDE Adverse Event Report: FISHER PAYKEL HEALTHCARE LIMITED FISHER PAYKEL HEALTHCARE; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Lot Number 01142

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 09/02/2023

Event Type  malfunction  

Event Description

From staff: particulate matter found in the fisher & paykel heater chamber.Manufacturer response for humidifier, respiratory gas, (direct patient interface), fisher paykel healthcare (per site reporter).Working with reps to figure out the reason for this issue with the growth of substance.They have not seen this reported and offered to test the chamber pot to see if they can discover what is going on and see if they help resolve.

• Brand Name: FISHER PAYKEL HEALTHCARE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER PAYKEL HEALTHCARE LIMITED; 17400 laguna canyon road., suite 300; irvine CA 92618
• MDR Report Key: 17904781
• MDR Text Key: 325287779
• Report Number: 17904781
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 01142
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 DA
• Patient Sex: Male
• Patient Weight: 2 KG