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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 AF5140MB
Device Problem Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/07/2016
Event Type  malfunction  
Event Description
While attempting to remove the mask, it was impossible to disconnect the mask following intubation.
 
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Brand NameAIRFLOW
Type of DeviceRESUS BAG
Manufacturer (Section D)
VENTLAB LLC.
2710 northridgedr. suite a
grand rapids MI 49544
Manufacturer (Section G)
VENTLAB LLC.
2710 northridgedr. suite a
grand rapids MI 49544
Manufacturer Contact
carrie fortuna
2710 northridge dr. suite a
grand rapids, MI 49544
6162598350
MDR Report Key5846094
MDR Text Key51748298
Report Number2246980-2016-00022
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
PMA/PMN Number
K012842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 08/03/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAF5140MB
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2016
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?
Type of Device Usage

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