MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE, INC. OPTIFLOW; CANNULA, NASAL, OXYGEN

Lot Number 2100725276

Device Problem Leak/Splash (1354)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/20/2019

Event Type  malfunction  

Event Description

Torn optiflow nasal cannula.Patient desaturates when leak occurs.Returns to baseline with new equipment that is intact.

• Brand Name: OPTIFLOW
• Type of Device: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, INC.; 173 technology dr; irvine CA 92618
• MDR Report Key: 9665129
• MDR Text Key: 177602392
• Report Number: 9665129
• Device Sequence Number: 1
• Product Code: CAT
• 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: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 2100725276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25185 DA
• Patient Weight: 78