MAUDE Adverse Event Report: VAPOTHERM, INC. PRECISION FLOW; HUMIDIFIER, RESPIRATORY GAS

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2016

Event Type  malfunction  

Event Description

Yellow triangle with exclamation point error occurred on vapotherm while on patient.The error cleared when restarted, but fio2 unstable and drifting to 21% when set at 100%.The vapotherm technical support indicated failure of main board.

• Brand Name: PRECISION FLOW
• Type of Device: HUMIDIFIER, RESPIRATORY GAS
• Manufacturer (Section D): VAPOTHERM, INC.; 22 industrial dr. suite 1--; exeter NH 03833
• MDR Report Key: 6169063
• MDR Text Key: 62216496
• Report Number: 6169063
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/29/2016,12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 11/29/2016
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 69 YR
• Patient Weight: 77