MAUDE Adverse Event Report: VAPOTHERM, INC. AERONEB; ADAPTER, NEBULIZER

Catalog Number AAA-1

Device Problem Detachment Of Device Component (1104)

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

Event Date 12/13/2017

Event Type  malfunction  

Event Description

The vapotherm aeroneb adapter for the precision flow vapotherm was being used with an aerogen nebulizer.The adapter pops out of place if an occlusion occurs or if not securely fit in place.These two items are provided and validated as being able to be used together by vapotherm.Currently this combination has only been used in the nicu due to its higher efficiency.If the system pops off it can potentially be dangerous to the patient or the staff.In this case, it was reported as occurring, but no patient was identified.The biomed department was able to reproduce the event.Since the event the vapotherm adapter and aerogen nebulizer are no longer used together.Per manufacturer's response to the site, the manufacturer recommended reducing the flow rate when securing the adapter and noted the issue would not occur if the adapter is on and properly secured.

• Brand Name: AERONEB
• Type of Device: ADAPTER, NEBULIZER
• Manufacturer (Section D): VAPOTHERM, INC.; 22 industrial dr suite 1; exeter NH 03833
• MDR Report Key: 7181951
• MDR Text Key: 96981477
• Report Number: 7181951
• Device Sequence Number: 1
• Product Code: CAF
• 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: Other
• Type of Report: Initial
• Report Date: 12/21/2017

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
• Device Catalogue Number: AAA-1
• Device Lot Number: 170615
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2018
• 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: AEROGEN NEBULIZER