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

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Low Oxygen Saturation (2477); Increased Respiratory Rate (2486)

Event Date 12/07/2019

Event Type  malfunction  

Event Description

Baby's spo2 kept dropping on the monitor.When going to assess baby, baby was calm and breathing fast.Vapotherm kept showing that there was a kink in the circuit.When respiratory therapist went to go assess the tube from patient to machine there was no kink.This device has been retired, it was used as a trade-in for a new device.

• 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: 10000396
• MDR Text Key: 189003436
• Report Number: 10000396
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2020
• Type of Device Usage: N
• Patient Sequence Number: 1