MAUDE Adverse Event Report: VAPOTHERM INC VAPOTHERM

Model Number PRECISION FLOW

Device Problems Device Operates Differently Than Expected (2913); Improper Flow or Infusion (2954)

Patient Problems Abnormal Blood Gases (1034); Respiratory Distress (2045)

Event Date 04/17/2015

Event Type  malfunction  

Event Description

Baby boy infant was born on (b)(6) 2015 with respiratory distress.Placed on heated high flow cannula (vapotherm) at 08:10.Infant's po2 was low and was repeated twice.The vapotherm circuit was changed out.The air flow from circuit did not feel like 5 liters per minute.Baby's saturation stayed at 100%, but the po2 on the abgs were suspect that the baby was not receiving full flow from the machine.At 13:30 vapotherm was changed out at the request of the physician.Machine tagged and taken to biomed.Supervisor notified.The po2 returned to baseline.User facility report #: (b)(4).

• Brand Name: VAPOTHERM
• Type of Device: VAPOTHERM
• Manufacturer (Section D): VAPOTHERM INC; 22 industrial dr; exeter NH 03833
• MDR Report Key: 4752409
• MDR Text Key: 5826647
• Report Number: MW5042503
• 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: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 3