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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CORPORATION AIRLIFE CARDIOPULMONARY RESUSCITATION AID KIT

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CAREFUSION CORPORATION AIRLIFE CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
Model Number 2K8036
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/16/2018
Event Type  malfunction  
Event Description
During mock codes, there have been multiple instances where the white cap that covers the monitoring side port on the mechanical resuscitator (ambu bag) opens. This results in ineffective bagging as the "as" goes through the port rather than to the patient.
 
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Brand NameAIRLIFE
Type of DeviceCARDIOPULMONARY RESUSCITATION AID KIT
Manufacturer (Section D)
CAREFUSION CORPORATION
26125 n. riverwoods blvd
mettawa IL 60045
MDR Report Key7758312
MDR Text Key116299519
Report Number7758312
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/07/2018
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2K8036
Device Catalogue Number2K8036
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/17/2018
Event Location Hospital
Date Report to Manufacturer08/07/2018
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?
Type of Device Usage

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