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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VAPOTHERM, INC. PRECISION FLOW; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
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VAPOTHERM, INC. PRECISION FLOW; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE) Back to Search Results
Catalog Number PRECISION FLOW
Device Problems Loss of Power (1475); Self-Activation or Keying (1557)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/05/2019
Event Type  malfunction  
Event Description
The vapotherm was reporting to be turning off independently by staff.They reported hearing alarms previously, and they were addressed but say the machine was turning off without their knowledge.Manufacturer response for vapotherm, vaptotherm (per site reporter), device was given to regional business director.
 
Event Description
The vapotherm was reporting to be turning off independently by staff.They reported hearing alarms previously, and they were addressed but say the machine was turning off without their knowledge.Manufacturer response for vapotherm, vaptotherm (per site reporter).Device was given to regional business director.
 
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Brand Name
PRECISION FLOW
Type of Device
HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
Manufacturer (Section D)
VAPOTHERM, INC.
100 domain dr
exeter NH 03833
MDR Report Key9295306
MDR Text Key165631349
Report Number9295306
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 10/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberPRECISION FLOW
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/06/2019
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/10/2019
Device Age6 YR
Event Location Hospital
Date Report to Manufacturer11/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age26280 DA
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