MAUDE Adverse Event Report: VAPOTHERM, INC. PRECISION FLOW®; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Device Problems Moisture Damage (1405); Loss of Power (1475)

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

Event Date 02/27/2017

Event Type  malfunction  

Event Description

Vapotherm stopped delivering flow.No alarm or error code noted.Manufacturer response for vapotherm, vapotherm (per site reporter): o2 sensor taking on moisture causing shutdown.

• Brand Name: PRECISION FLOW®
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VAPOTHERM, INC.; 22 industrial dr. suite 1--; exeter NH 03833
• MDR Report Key: 6427317
• MDR Text Key: 70680443
• Report Number: 6427317
• 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: 03/16/2017,03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Other Device ID Number: 20034215
• 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: 03/16/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 59 YR