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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)
Patient Problems Not Applicable (3189); Missing Value Reason (3192)
Event Date 09/01/2016
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 cannot be removed from the bag without breaking." 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 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 Key6072133
MDR Text Key58936838
Report Number2246980-2016-00062
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 10/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberAF1140MB
Device Lot Number306415
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/06/2016
Initial Date FDA Received11/02/2016
Was Device Evaluated by Manufacturer? Yes
Type of Device Usage N
Patient Sequence Number1
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