MAUDE Adverse Event Report: VAPOTHERM VAPOTHERM PRECISION FLOW; HUMIDIFIER, RESPIRATORY, GAS (DIRECT PATIENT INTERFACE)

Model Number PRECISION FLOW

Device Problems Loss of Power (1475); Failure to Power Up (1476); No Flow (2991)

Patient Problems Hypoxia (1918); Neurological Deficit/Dysfunction (1982)

Event Date 08/14/2019

Event Type  malfunction  

Event Description

Hospitalized copd pt was on vapotherm precision flow device when nursing staff discovered the pt was hypoxic with associated altered mental status requiring immediate intervention.It was noted by nursing staff responding to the code that the vapotherm had shut off.The device wasn't beeping prior to the event (as per discussion with the nurse who was in the room prior to the event and the family who had also been present in the room before and during the event).The machine would not immediately turn back on.The machine was taken out of service and turned back on.It appeared to be working again.We inspected the wall plugs and they were functioning properly.We ran the machine again to try to shut it off and it seemed to be operating fine.We unplugged it and it sounded an audible alert for sometime before shutting down.We do not know why this unit shutdown with no warning while in use on a pt.Fda safety report id# (b)(4).

• Brand Name: VAPOTHERM PRECISION FLOW
• Type of Device: HUMIDIFIER, RESPIRATORY, GAS (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VAPOTHERM; exeter NH 03833
• MDR Report Key: 8939799
• MDR Text Key: 156388168
• Report Number: MW5089387
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 00841737100140
• UDI-Public: 00841737100140
• Combination Product (y/n): N
• 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: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 67