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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VAPOTHERM, INC. VAPOTHERM; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
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VAPOTHERM, INC. VAPOTHERM; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) Back to Search Results
Model Number PF-PLUS
Device Problem Device Displays Incorrect Message (2591)
Patient Problems Low Oxygen Saturation (2477); Confusion/ Disorientation (2553)
Event Date 11/03/2017
Event Type  malfunction  
Event Description
Rapid response was called over head for pt.Rapid response entered pt room and pt was disoriented.It was not possible to obtain a good spo2 on pt.The ambu bag was grabbed and started bagging pt.Rn stated that the vapotherm was alarming.I was unable to see the vapotherm from head of bed and continued bagging pt at flush.We were able to get a spo2 on the pt, which started around spo2 of 65%.After a couple of minutes of bagging, pt's spo2 was 95%.Pt was placed on high-flow nasal cannula (hfnc) at 15l 95%.Pt is being transferred to icu.
 
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Brand Name
VAPOTHERM
Type of Device
HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
Manufacturer (Section D)
VAPOTHERM, INC.
22 industrail dr.
suite 1
exeter NH 03833
MDR Report Key7147434
MDR Text Key95815067
Report Number7147434
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 Risk Manager
Type of Report Initial
Report Date 11/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2017
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberPF-PLUS
Other Device ID NumberCEID 10026271
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/21/2017
Device Age2 MO
Event Location Hospital
Date Report to Manufacturer11/21/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age60 YR
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