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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VAPOTHERM, INC. VAPOTHERM; HUMIDIFIER, RESPIRATORY GAS
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VAPOTHERM, INC. VAPOTHERM; HUMIDIFIER, RESPIRATORY GAS Back to Search Results
Catalog Number PF-DPC-LOW
Device Problems Device Operates Differently Than Expected (2913); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Respiratory Distress (2045)
Event Date 06/22/2014
Event Type  malfunction  
Event Description
The patient was changed over to high flow nasal cannula (hfnc) via vapotherm from ram cpap.The vapotherm circuit created a continuous lavage into patient nares.This made the patient cough and gag.The patient remained stable throughout and required much oral suctioning via rn at bedside.I made multiple attempts to minimize the conditions.I changed the flow, temperature, and double checked the integrity of all connections.I changed cannulas.My efforts made no difference.I changed the vapotherm circuit and the problem was alleviated.I saved and tagged the equipment.
 
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Brand Name
VAPOTHERM
Type of Device
HUMIDIFIER, RESPIRATORY GAS
Manufacturer (Section D)
VAPOTHERM, INC.
22 industrial drive suite 1
exeter NH 03833
MDR Report Key5387884
MDR Text Key36752316
Report Number5387884
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/19/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Catalogue NumberPF-DPC-LOW
Device Lot NumberLF1404014
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/19/2015
Event Location Hospital
Date Report to Manufacturer11/19/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/25/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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