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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 2200, INC. CAREFUSION PEDIATRIC RESUSCITATION BAG PULMONARY RESUSCITATOR, MANUAL, REUSABLE

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CAREFUSION 2200, INC. CAREFUSION PEDIATRIC RESUSCITATION BAG PULMONARY RESUSCITATOR, MANUAL, REUSABLE Back to Search Results
Device Problem Defective Device (2588)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/26/2019
Event Type  malfunction  
Event Description
We had a pediatric bag fail on us in the emergency room. Crna's were intubating an (b)(6) male patient. After they tubed the child they could not get chest rise with bagging. The pop off valve seemed to be defective. Rt got them another pediatric bag and it worked just fine. The problem was quickly identified and no harm was done to the patient. The bag was taken out of service.
 
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Brand NameCAREFUSION PEDIATRIC RESUSCITATION BAG
Type of DevicePULMONARY RESUSCITATOR, MANUAL, REUSABLE
Manufacturer (Section D)
CAREFUSION 2200, INC.
75 north fairway drive
vernon hills IL 60061
MDR Report Key9636279
MDR Text Key176585387
Report Number9636279
Device Sequence Number1
Product Code BTM
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 01/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/09/2020
Event Location Hospital
Date Report to Manufacturer01/28/2020
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? No
Type of Device Usage

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