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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 Problem Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/09/2017
Event Type  malfunction  
Event Description
Patient was being bag/mask ventilated; once endotracheal tube placed, attempted to remove mask from the resuscitation bag and the mask was unable to be removed from the resuscitation bag.
 
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Brand NameAIRLIFE
Type of DeviceCARDIOPULMONARY RESUSCITATION AID KIT
Manufacturer (Section D)
CAREFUSION CORPORATION
22745 savi ranch parkway
yorba linda CA 92887
MDR Report Key6442159
MDR Text Key71119333
Report Number6442159
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 03/17/2017,03/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2017
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/02/2021
Device Model Number2K8805
Device Catalogue Number2K8005
Device Lot Number0001030580
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/17/2017
Event Location Hospital
Date Report to Manufacturer03/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/29/2017 Patient Sequence Number: 1
Treatment
PATIENT WAS BEING INTUBATED, BAG/VALVE MASK BEING
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