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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CAREFUSION AMBUBAG

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CAREFUSION CAREFUSION AMBUBAG Back to Search Results
Model Number 2K8005
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/27/2017
Event Type  Injury  
Event Description
During code blue event, patient was intubated but no chest rise with the use of adult manual resuscitator (ambu bag) noted. Reintubation was reattempted; however no chest rise with use of same manual resuscitator device. Patient reintubated to ensure proper placement of endotracheal tube when it was determined that the issue was not placement of the endotracheal tube, but rather the issue was the manual resuscitator was not functioning properly (positive pressure was not being delivered to patient). The faulty device was immediately replaced and the patient was properly ventilated (chest rise was noted with the use of the replaced ambu bag). Dates of use: (b)(6) 2017. Is the product compounded: no. Is the product over-the-counter: no. Event abated after use stopped or dose reduced: yes. Event reappeared after reintroduction: doesn't apply.
 
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Brand NameCAREFUSION
Type of DeviceAMBUBAG
Manufacturer (Section D)
CAREFUSION
yorba linda CA 92887
MDR Report Key6543757
MDR Text Key74542953
Report NumberMW5069564
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 05/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/03/2022
Device Model Number2K8005
Device Lot Number0001040664
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: 05/02/2017 Patient Sequence Number: 1
Treatment
INTUBATION WITH THE USE OF AN ENDOTRACHEAL TUBE; VIA FAULTY DEVICE - MANUAL RESUSCITATOR (AMBU BAG); WITH POSITIVE PRESSURE ADMINISTRATION NEEDED
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