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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC CARDIOPULMONARY RESUSCITATION AID KIT

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CAREFUSION, INC CARDIOPULMONARY RESUSCITATION AID KIT Back to Search Results
Model Number 2K8005
Device Problem Failure to Disconnect (2541)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/09/2016
Event Type  Injury  
Manufacturer Narrative
Initial emdr submission. At this time we are awaiting the return of the device from the customer. The customer has been provided a shipping label. If any additional information becomes available a supplemental report will be filed. Patient code: (b)(4). Device code: (b)(4).
 
Event Description
Customer reported ¿while rt staff responded to a code blue situation of a non intubated patient were able to bag patient without incident however as patient had an airway (ett) established therapist was unable to remove mask to apply the 15ml adapter. There was no patient harm to this patient but there was a minor delay in ventilating the patient while a new bag was gathered. The mask was very difficult to remove, but after the patient was stabilized we messed around with the bag again and eventually after multiple people tried we were able to remove the mask from the bag".
 
Manufacturer Narrative
Follow up submission investigation results: one opened sample was received for evaluation. The unit was submitted to a functional inspection in accordance to procedure and no issues related to the customer report were found. The device history record was reviewed for the lot number reported and no issues were found. Despite that the product sample did not present the issue reported. Based on similar reports a probable root cause is related to the current mirror finish on the surface of the elbow connector. This mirror finish can make it difficult to remove the mask from the component. The elbow connector will now have a brushed surface to allow for the mask to be removed easily. A capa was initiated to further investigate this issue.
 
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Brand NameCARDIOPULMONARY RESUSCITATION AID KIT
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 Key6120880
MDR Text Key60675698
Report Number8030673-2016-00261
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 consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/30/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2K8005
Device Lot Number0000979971
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2017
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: 11/22/2016 Patient Sequence Number: 1
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