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

Device Problems No Display/Image (1183); Failure to Deliver (2338); Protective Measures Problem (3015)

Patient Problem Respiratory Arrest (4461)

Event Date 02/21/2022

Event Type  Injury  

Event Description

Hiflow nasal cannula 100% oxygen (40l/min) - machine screen displayed an error message (screen was black, showing only the caution symbol) with no oxygen being delivered to patient.Patient had respiratory arrest (resuscitated).A vapotherm rep came to the hospital to test the device but could not replicate the error.Device was removed from service, to be returned to manufacturer once replacement obtained.Fda safety report id# (b)(4).

• Brand Name: HIFLOW NASAL CANNULA MACHINE
• Type of Device: HIGH FLOW/HIGH VELOCITY HUMIDIFIED OXYGEN DELIVERY DEVICE
• Manufacturer (Section D): VAPOTHERM INC.
• MDR Report Key: 14282655
• MDR Text Key: 290792933
• Report Number: MW5109501
• 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: 04/29/2022

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: 05/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Female