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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION AIRLIFE MANUAL RESUSCITATOR II

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CAREFUSION AIRLIFE MANUAL RESUSCITATOR II Back to Search Results
Catalog Number 2K7012
Device Problem Product Quality Problem (1506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/17/2017
Event Type  Injury  
Event Description
Unsafe design discovered in airlife manual resuscitator bvm device. It is possible to interchange the facemask portion of the bag into the exhalation filter opening which creates a situation where you are not ventilating a pt at all.
 
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Brand NameAIRLIFE MANUAL RESUSCITATOR II
Type of DeviceAIRLIFE MANUAL RESUSCITATOR II
Manufacturer (Section D)
CAREFUSION
san diego CA
MDR Report Key6352625
MDR Text Key68245676
Report NumberMW5068041
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 02/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K7012
Was Device Available for Evaluation? Yes
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

Patient Treatment Data
Date Received: 02/22/2017 Patient Sequence Number: 1
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