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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 Problem Difficult to Remove (1528)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/03/2017
Event Type  Injury  
Manufacturer Narrative
Initial emdr submission: multiple attempts have been made to the customer to gain the sample and additional information regarding the patient involved. If any additional information becomes available, a supplemental submission will be filed.
 
Event Description
The mask on the ambu-bag cannot be removed during a code. It seems the ambu-bags with the yellowish mask are the ones that cannot be removed. Reported item was being used on patient. Patient harm or medical intervention unknown at this time.
 
Manufacturer Narrative
Follow up submission: six unopened samples were received for evaluation with lot number 0001002018. The units were submitted to a functional inspection and only one of the samples was unable to disconnect the mask from the resus bag. The manufacturing process was reviewed. Based on the investigation the root cause is considered to be related to the current mirror like surface on the elbow, part number 12276939, which makes the mask very difficult to remove. To correct this issue, the elbow will now contain a brushed surface which will allow the mask to be removed easily. (b)(4).
 
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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 Key6272877
MDR Text Key65604466
Report Number8030673-2017-00277
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8005
Device Lot Number0001002018
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2017
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?
Type of Device Usage

Patient Treatment Data
Date Received: 01/24/2017 Patient Sequence Number: 1
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