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

Device Problems No Audible Alarm (1019); Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2022

Event Type  Injury  

Event Description

The oxygen high flow machine - vapotherm was noted to not be working on a patient.The machine did not initially sound alarm.Patient required further treatment.Fda safety report id # (b)(4).

• Brand Name: PRECISION FLOW HI-VNI
• Type of Device: HIGH FLOW/HIGH VELOCITY HUMIDIFIED OXYGEN DELIVERY DEVICE
• Manufacturer (Section D): VAPOTHERM INC.; 100 domain drive; exeter NH 03833
• MDR Report Key: 15563058
• MDR Text Key: 301507340
• Report Number: MW5112497
• 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: 10/05/2022

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 MO
• Patient Sex: Male
• Patient Weight: 9 KG
• Patient Ethnicity: Hispanic