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

Model Number PF-UNIT

Device Problem Unexpected Shutdown (4019)

Patient Problem Airway Obstruction (1699)

Event Date 04/16/2020

Event Type  malfunction  

Event Description

Unit shut off while on patient.Code 57 was displayed.Manufacturer response for vapotherm, precision flow (per site reporter).Mfg rep came in, tested unit, found no problem.Code 57 indicates a patient airway blockage and the unit will shut down if that happens.

• 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: 10355352
• MDR Text Key: 201340587
• Report Number: 10355352
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/28/2020

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
• Device Operator: No Information
• Device Model Number: PF-UNIT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2020
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1