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

Model Number PT101US

Device Problem No Flow (2991)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/11/2020

Event Type  malfunction  

Event Description

Respiratory therapists were called to assist with patient with oxygen saturation level was in 70s and dropping.They noted the airvo hiflow nasal canula was not allowing flow to patient.This was replaced with another canula which allowed oxygen saturation level to improve.

• 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: 10860019
• MDR Text Key: 216921352
• Report Number: 10860019
• 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: 10/20/2020

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: 10/20/2020
• Date Report to Manufacturer: 11/18/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/18/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22995 DA