MAUDE Adverse Event Report: VAPOTHERM, INC; HUMIDIFIER, RESPIRATORY GAS

Catalog Number PF-DPC

Device Problems Material Discolored (1170); Device Contamination with Chemical or Other Material (2944); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 11/08/2014

Event Type  malfunction  

Event Description

A vapotherm precision flow high flow nasal canual was in use on the patient.Staff noticed an unfamiliar sound, no water flow through the tubing, and the tubing was discolored.There is a black substance inside the tubing.The tubing and cartridge were both replaced and the vapotherm operated properly.

• Type of Device: HUMIDIFIER, RESPIRATORY GAS
• Manufacturer (Section D): VAPOTHERM, INC; 22 industrial drive, suite 1; exeter NH 03833
• MDR Report Key: 4506582
• MDR Text Key: 5411115
• Report Number: 4506582
• Device Sequence Number: 1
• Product Code: BTT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 01/06/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: PF-DPC
• Device Lot Number: LF1407013
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO.
• Patient Age: 2 MO