MAUDE Adverse Event Report: VAPOTHERM INC. VAPOTHERM

Model Number PRECISION FLOW

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)

Event Date 08/11/2015

Event Type  malfunction  

Event Description

The pt was on vapotherm and the liter flow which was found to be insufficient at settings of 51pm.At 1630 on 08/11/2015 the pt was placed on vapotherm at 5 liters per minute and 100% fio2.At 1839 arterial blood gases were 7.30 ph, 48 co2, 75 po2.At 1900, spo2 96%, hr 142, rr 81.Heart rate was 13, reparatory rate was 35 with o2 sats of 99.Pt placed on replacement vapotherm and then returned to baseline.

• Brand Name: VAPOTHERM
• Type of Device: VAPOTHERM
• Manufacturer (Section D): VAPOTHERM INC. ; 22 industrial dr.; exeter NH 03833
• MDR Report Key: 5113791
• MDR Text Key: 27181459
• Report Number: MW5056622
• 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
• Report Date: 09/04/2015

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
• Device Model Number: PRECISION FLOW
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Weight: 3