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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC RESUS, ADLT W/MASK, 40" TBG, 6/CS CARDIOPULMONARY RESUSCITATION AID KIT

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CAREFUSION, INC RESUS, ADLT W/MASK, 40" TBG, 6/CS CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
Catalog Number 2K8005
Device Problems Failure to Disconnect (2541); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/26/2016
Event Type  Injury  
Manufacturer Narrative
At this time, the customer stated that no additional information is available. If additional information becomes available, it will be submitted in a follow up report. (b)(4). At this time, no sample is available.
 
Event Description
After patient was intubated, staff attempted to remove mask from ambu bag. Ambu bag would not disconnect from mask. When another staff member was finally able to pull apart it came apart at wrong area causing the bvm to be broken/unusable. Patient was quickly placed on vent and bilateral breath sounds were heard.
 
Manufacturer Narrative
Follow up emdr submission, investigation results: a sample was not provided for evaluation. However based on similar investigations the probably root cause is the mirror like finish on the elbow with part number 12276939 can make the mask very difficult to remove by creating suction like affect between the two components. To correct this issue the elbow will now have a brushed finished surface which will allow the mask to be removed easily. A capa has been opened to further investigate the root cause of the failure reported.
 
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Brand NameRESUS, ADLT W/MASK, 40" TBG, 6/CS
Type of DeviceCARDIOPULMONARY RESUSCITATION AID KIT
Manufacturer (Section D)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
Manufacturer (Section G)
CAREFUSION, INC
cerrada vía de la producción
no. 85., parque industrial mex
mexicali baja california norte
MX
Manufacturer Contact
jill rittorno
22745 savi ranch parkway
yorba linda, CA 92887
MDR Report Key6074141
MDR Text Key59010860
Report Number8030673-2016-00256
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
ENFORCEMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8005
Device Lot Number944395
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/02/2016 Patient Sequence Number: 1
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