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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VAPOTHERM INC. PRECISION FLOW HI-VNI; HIGH FLOW/HIGH VELOCITY HUMIDIFIED OXYGEN DELIVERY DEVICE
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VAPOTHERM INC. PRECISION FLOW HI-VNI; HIGH FLOW/HIGH VELOCITY HUMIDIFIED OXYGEN DELIVERY DEVICE Back to Search Results
Device Problems Output below Specifications (3004); Protective Measures Problem (3015)
Patient Problems Cardiac Arrest (1762); Dyspnea (1816); Loss of consciousness (2418); Diminished Pulse Pressure (2606)
Event Date 09/01/2021
Event Type  Death  
Event Description
Patient was on non-rebreather mask at 100% 02 vapotherm hi-flow nasal cannula.At approximately 0030 the vapotherm started alarming, showing temp setting as low.Nurse contacted the respiratory therapist that there was an issue with the vapotherm.Therapist noted on arrival that there was a heater malfunction, at this time the patient was awake and conversing with nurse.At 0052 suddenly the patient became unresponsive, no pulse, no respirations.Code blue was called, patient was intubated, regained rosc, was coded two more occasions and eventually expired at 0126.Patient presented with worsening difficult breathing, shortness of breath, covid-19 positive 8 days prior to arrival.Fda safety report id # (b)(4).
 
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Brand Name
PRECISION FLOW HI-VNI
Type of Device
HIGH FLOW/HIGH VELOCITY HUMIDIFIED OXYGEN DELIVERY DEVICE
Manufacturer (Section D)
VAPOTHERM INC.
exeter NH 03833
MDR Report Key12480820
MDR Text Key271890031
Report NumberMW5103975
Device Sequence Number1
Product Code QAV
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/14/2021
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 Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/15/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age52 YR
Patient Weight92
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