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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 Problems Disassembly (1168); Separation Failure (2547); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/25/2017
Event Type  malfunction  
Event Description
Resuscitation malfunctioned- mask could not be separated from bag after several attempts. Mask-valve-assemble came apart.
 
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Brand NameVENTLAB
Type of DeviceRESUSCITATION BAG
Manufacturer (Section D)
VENTLAB
grand rapids MI 49544
MDR Report Key6290002
MDR Text Key66317158
Report NumberMW5067551
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 01/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/17/2021
Device Model NumberAF1140MB
Device Lot Number305288
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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