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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTLAB AIRFLOW RESUS BAG

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VENTLAB AIRFLOW RESUS BAG Back to Search Results
Model Number AF1100MBS
Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)
Patient Problems Not Applicable (3189); Missing Value Reason (3192)
Event Date 09/26/2017
Event Type  malfunction  
Manufacturer Narrative
The customer alleges that there was no valve or manometer in the bag. " no other details were provided and no patient injury/harm reported. The affected device was not returned. Samples of the product were visually inspected from inventory all were confirmed with a manometer/valve attached to the bag and all components were present. The batch record was reviewed and there were no non-conformances.
 
Event Description
The customer alleges that " when ambu bag was opened it had the mask and bag, but no valve or manometer attached. " 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
2710 northridge dr.
suite a
grand rapids MI 49544
Manufacturer (Section G)
VENTLAB
2710 northridge dr.
suite a
grand rapids MI 49544
Manufacturer Contact
carrie fortuna
2710 northridge dr.
suite a
grand rapids, MI 49544
6162598400
MDR Report Key6973421
MDR Text Key90791910
Report Number2246980-2017-00026
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K935633
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAF1100MBS
Device Lot Number310403
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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