MAUDE Adverse Event Report: VAPOTHERM INC. VAPOTHERM HIGH FLOW NASAL CANNULA; HIGH FLOW/HIGH VELOCITY HUMIDIFIED OXYGEN DELIVERY DEVICE

Patient Problem Pneumothorax (2012)

Event Date 10/02/2023

Event Type  malfunction  

Event Description

Patient was placed on hfnc (high flow nasal cannula) on 100% for treatment of a pneumothorax.The hfnc started alarming and displaying code 55 error code.Vapotherm 37.

• Brand Name: VAPOTHERM HIGH FLOW NASAL CANNULA
• Type of Device: HIGH FLOW/HIGH VELOCITY HUMIDIFIED OXYGEN DELIVERY DEVICE
• Manufacturer (Section D): VAPOTHERM INC.
• MDR Report Key: 18486968
• MDR Text Key: 332783685
• Report Number: MW5150096
• Device Sequence Number: 1
• Product Code: QAV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/05/2024

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: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2024
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Race: White