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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTLAB VENTLAB RESUSCITATION BAG

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VENTLAB VENTLAB RESUSCITATION BAG Back to Search Results
Model Number AF1140MB
Device Problem Disassembly (1168)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/11/2017
Event Type  malfunction  
Event Description
Ambu bag fell apart while intubating pt.
 
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Brand NameVENTLAB RESUSCITATION BAG
Type of DeviceRESUSCITATION BAG
Manufacturer (Section D)
VENTLAB
grand rapids MI 49544
MDR Report Key6335696
MDR Text Key67711821
Report NumberMW5067908
Device Sequence Number1
Product Code BTM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/14/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/16/2021
Device Model NumberAF1140MB
Device Lot Number305288
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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