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

Model Number 24

Patient Problem Insufficient Information (4580)

Event Date 11/26/2023

Event Type  malfunction  

Event Description

Oxygen displayed two lines instead of o2 concentration.

• Brand Name: VAPOTHERM
• Type of Device: HIGH FLOW/HIGH VELOCITY HUMIDIFIED OXYGEN DELIVERY DEVICE
• Manufacturer (Section D): VAPOTHERM INC.
• MDR Report Key: 18486900
• MDR Text Key: 332874386
• Report Number: MW5150092
• Device Sequence Number: 1
• Product Code: QAV
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Device Model Number: 24
• Was Device Available for Evaluation?: Yes
• 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: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian