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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 MANUAL EMERGENCY VENTILATOR

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CAREFUSION, INC RESUS, ADLT W/MASK, 40" TBG, 6/CS MANUAL EMERGENCY VENTILATOR Back to Search Results
Catalog Number 2K8005
Device Problem Separation Failure (2547)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/07/2016
Event Type  Injury  
Manufacturer Narrative
At this time, the customer has not responded to requests for additional information regarding this event. If additional information becomes available, it will be submitted in a follow up report. (b)(4).
 
Event Description
The clinical staff reported that after the patient was intubated, when they tried to remove the mask to ventilate with the bag directly to the endotracheal tube, that they rarely could disconnect the mask.
 
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 DeviceMANUAL EMERGENCY VENTILATOR
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 Key5999489
MDR Text Key56453398
Report Number8030673-2016-00239
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 company representative,health
Reporter Occupation
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 Received10/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8005
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: 10/05/2016 Patient Sequence Number: 1
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