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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 AF1140MB
Device Problems Device Issue (2379); Separation Failure (2547); Device Operational Issue (2914)
Patient Problems Not Applicable (3189); Missing Value Reason (3192)
Event Date 01/26/2017
Event Type  malfunction  
Manufacturer Narrative
An extensive and thorough investigation was performed by the engineering team that concluded the root cause for this problem is the fact that the patient port and the mask are made out of similar base materials resulting in an undesirably high coefficient of friction between the two parts. Steps have been taken to implement a material combination with a lower coefficient of friction that significantly reduces the effort required to remove the mask from the patient valve.
 
Event Description
The customer alleges "the mask is difficult to remove. " 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 Key6353252
MDR Text Key68214507
Report Number2246980-2017-00009
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
Type of Report Initial
Report Date 01/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAF1140MB
Device Lot Number305288
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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