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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 AF1100MBS
Device Problem Sticking (1597)
Patient Problem No Information (3190)
Event Date 07/09/2016
Event Type  malfunction  
Event Description
Mask would not come off elbow.After pulling to get mask off, it pulled elbow out of bag housing.
 
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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 Key5849680
MDR Text Key52309241
Report Number2246980-2016-00026
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 07/13/2016
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 NumberAF1100MBS
Device Lot Number305061
Initial Date Manufacturer Received 07/13/2016
Initial Date FDA Received08/05/2016
Type of Device Usage N
Patient Sequence Number1
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