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U.S. Department of Health and Human Services

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

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CAREFUSION/BD RESUS, ADLT W/MASK, 40" TBG, 6/CS CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
Catalog Number 2K8005
Device Problem Failure to Disconnect (2541)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/27/2017
Event Type  Injury  
Manufacturer Narrative
Additional information: unfortunately the device sample was not available for further investigation. At this time the unable to disconnect failure mode cannot be confirmed. However based on similar complaints as a probable root cause it is considered that the current mirror finish surface on the elbow makes the mask very difficult to remove. The new textured surface finish on the elbow allows the mask to be easily removed as indented. A corrective and preventative action has also been opened to further investigate into this known failure mode.
 
Manufacturer Narrative
It has been confirmed by carefusion/bd that the complaint sample is not available for evaluation. Attempts have been made by customer advocacy to gain additional information from the customer and end user regarding the situation reported with the device. If a sample or any additional information becomes available a follow up emdr will be submitted. (b)(4).
 
Event Description
The customer reported: ¿after a successful intubation, i could not remove the mask from the bag valve mask (bvm). I handed the bvm to a co-worker whom also struggled to remove the mask from the bvm. I went to grab another bvm but he was then able to free the mask from the bvm¿. The customer did not provide any information regarding patient consequence as a result of the reported issue, it is currently unknown.
 
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Brand NameRESUS, ADLT W/MASK, 40" TBG, 6/CS
Type of DeviceCARDIOPULMONARY RESUSCITATION AID KIT
Manufacturer (Section D)
CAREFUSION/BD
cerrada vía de la producción
no. 85 parque industrial
mexicali baja california norte
MX
Manufacturer (Section G)
CAREFUSION/BD
cerrada vía de la producción
no.85 parque industrial
mexicali baja california norte
MX
Manufacturer Contact
mindy faber
75 north fairway drive
vernon hills, IL 60061
MDR Report Key6564700
MDR Text Key110609069
Report Number8030673-2017-00333
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,user faci
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 06/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2017
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 Received06/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction Number8030673-4/27/17-002-R

Patient Treatment Data
Date Received: 05/12/2017 Patient Sequence Number: 1
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