MAUDE Adverse Event Report: VAPOTHERM INC. VAPOTHERM

Device Problems No Flow (2991); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 10/14/2015

Event Type  malfunction  

Event Description

At 1930, the pt was placed on precision flow vapotherm #9 at 51pm, 100% fio2.Hr 155, rr 33, spo2 100%.At 2004, abg was 7.35, 35 co2, 374 po2, 19 hco3.At approx 2100, rn said machine began to alarm.The alarm icon indicated a blocked tube, possibly due to an obstructed or kinked cannula or circuit.The rn took off the nasal cannula and noticed there was no oxygen flow coming from the machine.She attempted to fix the circuit and cannula, but the machine continued to alarm and there was no oxygen flow present.The rn called the rt who also confirmed there was no flow and stated machine was making a "rattling noise".The rt changed out the machine with a new vapotherm and circuit; (b)(4).

• Brand Name: VAPOTHERM
• Type of Device: VAPOTHERM
• Manufacturer (Section D): VAPOTHERM INC. ; 22 industrial dr. ; exeter NH 03833
• MDR Report Key: 5214066
• MDR Text Key: 31031495
• Report Number: MW5057779
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/27/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 4