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

Device Problems Therapeutic or Diagnostic Output Failure (3023); Noise, Audible (3273)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/05/2021

Event Type  malfunction  

Event Description

The intensivist was in the patient room when she heard the vapotherm make a strange sound while on the patient.There was no audible alarm and the device had power to it.The patient started to desaturate into the 50's and it was suspected at that time that there was a change in pressure from the device to the patient.The patient was removed from vapotherm and placed on bipap and oxygen saturations improved.This reporting therapist pulled the vapotherm device and sequestered it.Letter from daughter says the hissing noise of the o2 stopped and he began to suffocate.Per provider, circuit did not appear to be kinked and there was nothing abnormal at the time the device malfunctioned.Circuit was not saved as it was a covid patient.Pm (preventative maintenance) was last performed (b)(6) 2021, at which time no issues were identified and the only things replaced were the annual pm kit items (o2 sensor, air and o2 filters).

• 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: 13224115
• MDR Text Key: 283611782
• Report Number: 13224115
• 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: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 01/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28470 DA
• Patient Sex: Male