MAUDE Adverse Event Report: VAPOTHERM VAPOTHERM; HUMIDIFIER

Device Problems Manufacturing, Packaging or Shipping Problem (2975); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Vapotherm is a device used in infants with respiratory distress syndrome or other respiratory problems.In neonates, the manufacturer recommends liter flow rates as high as 8 liters per minute.Neonates are at increased risk of hearing loss if cared for in the nicu.We try to minimize noise levels with single family rooms, quieter ventilators and incubators, among other strategies.I have measured decibel levels with vapotherm at 8 liters, and have seen levels in the 90s, comparable to being in a noisy new york city subway car.Has the manufacturer commented on the impact of this sort of noise level on a very low birth weight infant for several weeks? if not is this something that the fda can require the manufacturer to study post-marketing to demonstrate no injury to the infant with respect to hearing?.

• Brand Name: VAPOTHERM
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): VAPOTHERM
• MDR Report Key: 7083400
• MDR Text Key: 93821239
• Report Number: MW5073740
• 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: Physician
• Type of Report: Initial
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability