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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 2K8805
Device Problems Sticking (1597); Failure to Disconnect (2541)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/01/2017
Event Type  malfunction  
Event Description
This month, our facility received an urgent recall from vyaire/carefusion regarding the airlife resuscitation device. The risk was described as: the potential patient safety risk associated with the sticking condition and difficult to/unable to disconnect malfunction may result in a delay in or inability to provide ventilation to the patient after placement of an advanced airway (tracheal or tracheostomy). After reviewing the alert, product was found by comparing the catalog and lot numbers against devices located in storage areas around the facility. We are now in the process of notifying the manufacturer of our findings and complying with their instructions. No known events of resuscitation delay or failure have been reported at this facility with the devices identified in the reported urgent recall from vyaire/carefusion. Manufacturer response for manual resuscitation device, airelife (per site reporter):.
 
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Brand NameAIRLIFE
Type of DeviceCARDIOPULMONARY RESUSCITATION AID KIT
Manufacturer (Section D)
CAREFUSION CORPORATION
75 n. fairway drive
vernon hills IL 60061
MDR Report Key6553565
MDR Text Key74724551
Report Number6553565
Device Sequence Number0
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/09/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2K8805
Device Catalogue Number2K8005
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/08/2017
Event Location No Information
Date Report to Manufacturer05/08/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Type of Device Usage

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