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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VAPOTHERM, INC VAPOTHERM PRECISION FLOW
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VAPOTHERM, INC VAPOTHERM PRECISION FLOW Back to Search Results
Model Number 85-PF-UNIT-US
Device Problems Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591); Programming Issue (3014)
Patient Problems Dyspnea (1816); Low Oxygen Saturation (2477)
Event Date 07/21/2014
Event Type  No Answer Provided  
Event Description
A (b)(6) in respiratory distress had been at 100% oxygen saturation on heated high flow nasal cannula on 100% fio2 at 5 l, temperature was 37c.At approx 1600, the high flow nasal cannula dropped the fio2 to 21% (room air) and started to alarm.The equipment and connections were verified and everything was secured and connected.The rn was unable to change the fio2 setting to 100% and the high flow nasal cannula continued to alarm.Respiratory therapist was called, and blow by oxygen was administered to the infant.The infant saturations dropped from 100% to 89% and was progressively more tachypneic.The neonatologist came to the bedside to assist as the infants saturations dropped to the 60's.The neonatologist bagged the infant and saturations corrected to high 90's, while respiratory therapist quickly replaced the high flow nasal cannula with a new high flow nasal cannula.The infant remained tachypneic but stable on the new high flow nasal cannula on 5l, fio2 100%, temperature was 37c.
 
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Brand Name
VAPOTHERM PRECISION FLOW
Type of Device
VAPOTHERM
Manufacturer (Section D)
VAPOTHERM, INC
22 industrial dr
ste 1
exeter NH 03833
MDR Report Key4080856
MDR Text Key15807597
Report NumberMW5038130
Device Sequence Number1
Product Code BTT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number85-PF-UNIT-US
Device Catalogue Number85-PF-UNIT-US
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/08/2014
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Weight3
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