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

Model Number 85-PF

Device Problems Loss of Power (1475); Noise, Audible (3273)

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

Event Date 12/12/2018

Event Type  malfunction  

Event Description

Patient on vapotherm 40lpm 60%.Er nurse heard a loud pop and went to room to find vapotherm machine off.Nurse placed patient on bipap which was at the bedside.Ed nurse tried to turn on vapotherm and noticed the on/off button was depressed inside facing.Machine changed out by respiratory therapist and taken to biomed for evaluation.

• Brand Name: VAPOTHERM
• Type of Device: HUMIDIFIER, RESPIRATORY GAS (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VAPOTHERM INC. ; exeter NH 03833
• MDR Report Key: 8231536
• MDR Text Key: 132912885
• Report Number: MW5082983
• 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: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 85-PF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 72