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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 AFW1140MB
Device Problems Failure to Deliver (2338); No Flow (2991)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/10/2017
Event Type  malfunction  
Manufacturer Narrative
Affected device returned and visually inspected. The returned device has been identified as product produced within the timeframe of our 2014 resus bag recall res 68242. First, visual inspection of the affected device demonstrated the material color of the diaphragms located at the opposite end of the manometer as green and red. We changed the color of all diaphragms to red on 26 jan 2015. Second, the affected device had a white pop-off cap below the integrated manometer. This was removed on 27 jan 2015. Third, the duckbill valve material was updated on 11 feb 2015. Review of the affected duckbill valve shows cavity designation as alphabetic "i". This cavity was used for the previous material. We conclude the affected device is from a lot number in the scope of recall res 68242. This recall was initiated on 08 may 2014 and deemed closed on 18 nov 2015.
 
Event Description
The customer alleges "the resus bag could not be squeezed and released as valve is sealed shut/not opening. " 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 Key6310241
MDR Text Key66772009
Report Number2246980-2017-00007
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
Remedial Action Recall
Type of Report Initial
Report Date 01/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAFW1140MB
Device Lot Number306878
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage
Removal/Correction NumberRES 68242

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