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

Model Number PRECISION FLOW

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 01/26/2024

Event Type  Injury  

Event Description

The vapotherm was set up appropriately and flow was confirmed.Shortly afterwards, the patient began exhibiting signs of respiratory distress.An emergency response was activated during which, it was noted that the vapotherm display was not illuminated.The numerical display was restored after interacting with it.

• Brand Name: VAPOTHERM PRECISION FLOW
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VAPOTHERM INC.; 100 domain drive; exeter NH 03833
• MDR Report Key: 18776841
• MDR Text Key: 336194803
• Report Number: 18776841
• Device Sequence Number: 1
• Product Code: BTT
• 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: 02/09/2024,02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: PRECISION FLOW
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2024
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 10 MO
• Patient Sex: Female
• Patient Weight: 6 KG
• Patient Ethnicity: Hispanic