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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VAPOTHERM, INC. VAPOTHERM STAND, INFUSION

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VAPOTHERM, INC. VAPOTHERM STAND, INFUSION Back to Search Results
Model Number PF-STAND-GCX
Device Problems Device Tipped Over (2589); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2021
Event Type  malfunction  
Event Description
There was a vapotherm high flow with air compressor running. Both were attached to a vapotherm wheelbase. The set-up, particularly the pole of the wheelbase with everything attached, started to fall over onto the patient. A nurse was present and was able to grab the equipment before it fell on to the patient. The machine continued running, treatment was not interrupted, and there was no harm to the patient. The machine was switched out and upon further inspection it was determined that the pole of the unit detached from the wheelbase because the screws attaching the two components were sheared off. We believe it may have been the vibration from the air compressor that caused this to occur. Staff have been instructed to place the compressor on the wheelbase to reduce the amount of stress on the pole. Manufacturer response for vapotherm: precision flow hi-vni stand, precision flow plus stand (per site reporter): the manufacturer stated this is the first time they have heard of this event and sent a replacement stand.
 
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Brand NameVAPOTHERM
Type of DeviceSTAND, INFUSION
Manufacturer (Section D)
VAPOTHERM, INC.
100 domain drive
exeter NH 03833
MDR Report Key13155224
MDR Text Key283241016
Report Number13155224
Device Sequence Number1
Product Code FOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberPF-STAND-GCX
Device Catalogue NumberPF-STAND-GCX
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/22/2021
Device Age23 MO
Event Location Hospital
Date Report to Manufacturer01/04/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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