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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 2200, INC. AIRLIFE VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

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CAREFUSION 2200, INC. AIRLIFE VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) Back to Search Results
Catalog Number 2K8018
Device Problems Inadequacy of Device Shape and/or Size (1583); Failure to Disconnect (2541)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/31/2017
Event Type  malfunction  
Event Description
The patient had a desaturation episode to the 60's during a treatment. The respiratory therapist went to use the resuscitation bag and mask, but the mask size was wrong and they were not able to disconnect the mask from bag to switch to a different size.
 
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Brand NameAIRLIFE
Type of DeviceVENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
Manufacturer (Section D)
CAREFUSION 2200, INC.
75 north fairway drive
vernon hills IL 60061
MDR Report Key6398586
MDR Text Key69758851
Report Number6398586
Device Sequence Number1
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 02/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/13/2017
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2K8018
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/17/2017
Event Location Hospital
Date Report to Manufacturer02/17/2017
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

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