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

Model Number PF-ADPC-HIGH

Device Problem Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Date 08/28/2020

Event Type  malfunction  

Event Description

The aerogen with vapotherm was not delivering medication.The nebulizer medication was bubbling in the nebulizer and no mist was visible.The vapotherm rep.Was notified and came to the facility.The staff tried to decrease the flow, but it did not change delivery.The nebulizer and cannula were changed with no different results.The rep.Was witness to the device failure.

• Brand Name: VAPOTHERM
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VAPOTHERM, INC.; 100 domain drive; exeter NH 03833
• MDR Report Key: 10527468
• MDR Text Key: 206729714
• Report Number: 10527468
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PF-ADPC-HIGH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA