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

Device Problem Output Problem (3005)

Patient Problem Low Oxygen Saturation (2477)

Event Date 12/24/2022

Event Type  malfunction  

Event Description

Received a page from rn (registered nurse) explaining the vapotherm in patient¿s room was not working properly causing the patient's o2 to desat triggering an alarm.Rn entered patient¿s room and placed the patient on the standby bipap unit.I troubleshooted the vapotherm but was unsuccessful in correcting the issue.I spoke with the respiratory head tech on duty about the issue immediately.I replaced the vapotherm with a working unit and placed the patient back on vapotherm with original settings.I notified rn of my actions.

• Brand Name: VAPOTHERM
• 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: 16157054
• MDR Text Key: 307275936
• Report Number: 16157054
• Device Sequence Number: 1
• Product Code: QAV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/10/2023

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
• 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: 01/10/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/13/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 33215 DA
• Patient Sex: Female
• Patient Weight: 55 KG
• Patient Race: White