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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 AF3140MB
Device Problem Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/13/2016
Event Type  malfunction  
Manufacturer Narrative
Based on the more severely deformed mask, these masks appear to have been deformed after they were manufactured. There is no reason to believe that they were escaping defects from production. They may have been stored in a manner where they were under a load that caused the masks to deform over time.
 
Event Description
The customer alleges "infant masks are warped and won't fit on the resus bag. " no other details were provided and no patient injury/harm reported.
 
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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 Key6273835
MDR Text Key65908189
Report Number2246980-2017-00005
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 12/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAF3140MB
Device Lot Number304864
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
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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