MAUDE Adverse Event Report: VAPOTHERM VAPOTHERM; HEATED HIGH FLOW O2

Model Number 85-PF-UNIT-US

Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591); Programming Issue (3014)

Patient Problem Adult Respiratory Distress Syndrome (1696)

Event Date 12/20/2014

Event Type  Injury  

Event Description

The vapotherm unit was found to be alarming.The fio2 was not reading and the flow was not unable to be adjusted, the patient was short of breath and anxious.The oxygen saturation was at 90%.The respirations were between 26-30 per minute.Upon auscultation, wheezing noted bilaterally in upper lobes and diminished lung sounds bilaterally in lower lobes.The patient was given a nebulizer treatment.The vapotherm unit was quickly changed out.During the switch of vapotehrm units, the patient's oxygen saturation temporarily dropped to 88%.Shortly thereafter the oxygenation saturation increased to 98% and respirations were 20 per minute.

• Brand Name: VAPOTHERM
• Type of Device: HEATED HIGH FLOW O2
• Manufacturer (Section D): VAPOTHERM; 22 industrial drive; exeter NH 03833
• MDR Report Key: 4434002
• MDR Text Key: 5381648
• Report Number: 4434002
• Device Sequence Number: 1
• Product Code: BTT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/31/2014

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: 85-PF-UNIT-US
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/29/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/02/2015
• Distributor Facility Aware Date: 12/21/2014
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/29/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 47 YR
• Patient Weight: 105