MAUDE Adverse Event Report: VAPOTHERM VAPOTHERM; PRECISION FLOW

Model Number PRECISION

Device Problems Device Alarm System (1012); Failure to Sense (1559); Obstruction of Flow (2423); Torn Material (3024)

Patient Problem No Information (3190)

Event Date 08/14/2016

Event Type  malfunction  

Event Description

Vapotherm was alarming low water.Attempts to reset the alarm were unsuccessful.The lower sensor in the cartridge well had a silicone cover that was torn and its flaps were partially obstructing the sensor.

• Brand Name: VAPOTHERM
• Type of Device: PRECISION FLOW
• Manufacturer (Section D): VAPOTHERM; exeter NH 03833
• MDR Report Key: 5905953
• MDR Text Key: 53375277
• Report Number: MW5064353
• Device Sequence Number: 1
• Product Code: BTT
• 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: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRECISION
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR