MAUDE Adverse Event Report: VAPOTHERM INC.; CANNULA, NASAL, OXYGEN

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Low Oxygen Saturation (2477)

Event Date 01/09/2021

Event Type  malfunction  

Event Description

According to the respiratory therapist, high flow nasal cannula was placed on the patient.The machine malfunctioned x3, turned off and caused the patient's spo2 to fall in the 80's.The high flow nasal cannula was replaced with another machine, same brand and operated as intended.

• Type of Device: CANNULA, NASAL, OXYGEN
• Manufacturer (Section D): VAPOTHERM INC.; 100 domain drive; exeter NH 03833
• MDR Report Key: 11257859
• MDR Text Key: 229591808
• Report Number: 11257859
• Device Sequence Number: 1
• Product Code: CAT
• 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: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 01/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18615 DA
• Patient Weight: 78