MAUDE Adverse Event Report: VAPOTHERM, INC PRECISION FLOW; VAPOTHERM HIGH FLOW CARTRIDGE

Catalog Number PF-DPC-HIGH

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2015

Event Type  malfunction  

Event Description

Vapotherm cartridge was assembled and water bag spiked.As the cartridge was filling, water was dripping out of the base of the cartridge (small steady stream).This happened on three other events over an approximate one week period for a total of 4 cartridges that responded this way when water spiked.Events never reached patients.

• Brand Name: PRECISION FLOW
• Type of Device: VAPOTHERM HIGH FLOW CARTRIDGE
• Manufacturer (Section D): VAPOTHERM, INC; 22 industrial drive; suite 1; exeter NH 03833
• MDR Report Key: 5334254
• MDR Text Key: 34651220
• Report Number: 5334254
• 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: Other
• Type of Report: Initial
• Report Date: 12/08/2015,12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: PF-DPC-HIGH
• Device Lot Number: HF1509006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1