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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTLAB LLC. AIRFLOW; RESUS BAG
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VENTLAB LLC. AIRFLOW; RESUS BAG Back to Search Results
Model Number AFW1140MB
Device Problems Appropriate Term/Code Not Available (3191); Missing Value Reason (3192)
Patient Problems No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)
Event Type  malfunction  
Manufacturer Narrative
During the course of the product investigation, visual and functional testing was performed on the returned product.The investigation confirmed the customer claim and a nonconformance has been opened to garner further investigation.
 
Event Description
The customer alleges that "the adapter opening of the mask is defective and as the plastic is more rigid than it used to be." no other details were provided and no patient injury/harm reported.
 
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Brand Name
AIRFLOW
Type of Device
RESUS BAG
Manufacturer (Section D)
VENTLAB LLC.
2710 northridge dr. suite a
grand rapids MI 49544
Manufacturer (Section G)
VENTLAB LLC.
2710 northridge dr. suite a
grand rapids MI 49544
Manufacturer Contact
carrie fortuna
2710 northridge dr. suite a
grand rapids, MI 49544
6162598400
MDR Report Key7063604
MDR Text Key93826786
Report Number2246980-2017-00033
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K012842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 11/01/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberAFW1140MB
Device Lot Number309894
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/07/2017
Type of Device Usage N
Patient Sequence Number1
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