MAUDE Adverse Event Report: VAPOTHERM PRECISION FLOW

Device Problems Material Discolored (1170); No Flow (2991)

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

Event Date 11/24/2017

Event Type  malfunction  

Event Description

Vapotherm alarmed low water.Water was full, however there was no flow.The tubing near the vapotherm was dark and there was some darkening on the vapotherm.No smoke was ever noted.Pt's vital signs remained stable.The pt was placed on a nrb mask while vapotherm was changed out.

• Brand Name: PRECISION FLOW
• Type of Device: PRECISION FLOW
• Manufacturer (Section D): VAPOTHERM; exeter NH 03833
• MDR Report Key: 7156959
• MDR Text Key: 96229345
• Report Number: MW5074323
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 75