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

Model Number PT101US

Device Problems No Flow (2991); Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 01/27/2021

Event Type  malfunction  

Event Description

Fisher & paykel healthcare airvo¿ 2 nasal high flow system turned off abruptly while providing oxygen and flow to the patient.After patient was stabilized, airvo¿ 2 nasal high flow system was replaced.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• 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: 11398470
• MDR Text Key: 234242591
• Report Number: 11398470
• 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: 02/23/2021

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: No Information
• Device Model Number: PT101US
• Device Catalogue Number: PT101US
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2021
• Date Report to Manufacturer: 03/02/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA