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

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 07/04/2021

Event Type  malfunction  

Event Description

Heater not functioning properly.

• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 173 technology dr; suite 100; irvine CA 92618
• MDR Report Key: 12330832
• MDR Text Key: 266876456
• Report Number: 12330832
• 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
• Type of Report: Initial
• Report Date: 08/09/2021,07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2021
• Date Report to Manufacturer: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1