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

Model Number	PRECISION FLOW
Health Effect - Clinical Codes	Hypoxia (1918); Neurological Deficit/Dysfunction (1982)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: HUMIDIFIER, RESPIRATORY, GAS (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VAPOTHERM; exeter NH 03833
• MDR Report Key: 8939799
• Report Number: MW5089387
• Device Sequence Number: 2087611
• Product Code: BTT
• UDI-Device Identifier: 00841737100140
• UDI-Public: 00841737100140
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/26/2019

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
• Operator of Device: Health Professional
• Device Model Number: PRECISION FLOW
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 67