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

Model Number PFPC00038423-E

Device Problems Defective Alarm (1014); Obstruction of Flow (2423); Material Twisted/Bent (2981)

Patient Problems Hypoxia (1918); Low Oxygen Saturation (2477)

Event Date 01/19/2022

Event Type  Injury  

Event Description

The patient was on cont bipap was placed on hfnc to eat on 40 lpm and 100% fio2.At 1250 rn found patient with o2 sat 13 unresponsive and turning purple per her documentation.Placed immediately on non-rebreather and sats came up to 89% and became responsive.Pt had been on and off on bipap prior to event.The hfnc was found kinked and not delivering flow to the patient.The unit did not alarm due to a kinked occluded tubing.The unit was sequestered in the rt dept.The vendor was immediately notified and has not had any reports of this issue.Patient condition seems no worse than previously.Patient is neurologically intact.Continues to have progression of covid but seems unrelated.Fda safety report id# (b)(4).

• Brand Name: VAPOTHERM HFNC
• Type of Device: HIGH FLOW/HIGH VELOCITY HUMIDIFIED OXYGEN DELIVERY DEVICE
• Manufacturer (Section D): VAPOTHERM INC.
• MDR Report Key: 13393436
• MDR Text Key: 284803646
• Report Number: MW5107060
• 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: 01/26/2022

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
• Device Model Number: PFPC00038423-E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male