MAUDE Adverse Event Report: VAPOTHERM INC. VAPOTHERM PF; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number 11070037

Device Problems Leak/Splash (1354); Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 10/25/2021

Event Type  Injury  

Event Description

Hfnc vapotherm was setup and placed on pt sterile water bag inflated during use excess water flowed out of circuit into pt nose.Fda safety report id # (b)(4).

• Brand Name: VAPOTHERM PF
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VAPOTHERM INC.
• MDR Report Key: 12771170
• MDR Text Key: 280545972
• Report Number: MW5105158
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 11070037
• Device Lot Number: HFTL28637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: STERILE WATER
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 118 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native