MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED OPTIFLOW JUNIOR; CANNULA, NASAL, OXYGEN

Model Number OPT314

Device Problem Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 02/24/2015

Event Type  malfunction  

Event Description

Burn related to high flow oxygen delivery system while patient prone.

• Brand Name: OPTIFLOW JUNIOR
• Type of Device: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15365 barranca parkway; irvine CA 92618
• MDR Report Key: 5063725
• MDR Text Key: 25229528
• Report Number: 5063725
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 04/14/2015,08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: OPT314
• Device Catalogue Number: OPT314
• Other Device ID Number: HIGH FLOW NASAL CANNULA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/14/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other