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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. AIRLIFE VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

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VYAIRE MEDICAL, INC. AIRLIFE VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) Back to Search Results
Model Number 2K8012
Device Problem Moisture Damage (1405)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/06/2020
Event Type  malfunction  
Event Description
One of our therapists was setting up a ventilator and noticed that the bacterial/viral filter she was going to use was damp/wet and had some condensation in it. We opened another filter and also noticed that it was wet/damp. I called the manufacturer to file a product concern with them. The manufacturer is vyaire. We opened several other filters and noticed that not all of them were damp/wet.
 
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Brand NameAIRLIFE
Type of DeviceVENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
Manufacturer (Section D)
VYAIRE MEDICAL, INC.
26125 nw riverwoods blvd
mettawa IL 60045
MDR Report Key10447619
MDR Text Key204193196
Report Number10447619
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/17/2020,08/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2K8012
Device Catalogue Number2K8012
Device Lot Number0004144635
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/17/2020
Event Location Hospital
Date Report to Manufacturer08/25/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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