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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 MANUAL EMERGENCY VENTILATOR

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CAREFUSION/BD RESUS, ADLT W/MASK, 40" TBG, 6/CS MANUAL EMERGENCY VENTILATOR Back to Search Results
Catalog Number 2K8005
Device Problem Failure to Disconnect (2541)
Patient Problem Respiratory Distress (2045)
Event Date 08/30/2016
Event Type  Injury  
Manufacturer Narrative
Carefusion has reached out to customer to provide the complaint device for further investigation. The sample was received in a carefusion general office and forwarded to the carefusion manufacturing facility for further evaluation. Once an evaluation is completed then a supplemental report will be submitted. (b)(4).
 
Event Description
The customer reported that the mask is difficult to remove when needed for intubation. The customer stated: "our er-physicians/clinical staff are having difficulty with removing the mask from the connector. The er physician demonstrated the difficulty with attempting to remove the mask from the device while a patient is in distress. The first mask he chose was impossible to remove from the connector, while checking a few more, we were able to eventually remove mask from the connector located in the "ambu-bag", although it was still too difficult". It was confirmed that there was patient involvement, delayed care for a patient in distress; otherwise no permanent harm or injury.
 
Manufacturer Narrative
Device evaluation: one representative sample was sent in for a detailed evaluation. The unit was submitted to a functional inspection, and the unit performed as intended, no issues were found. Therefore the reported failure mode could not be confirmed. Carefusion/bd concluded that that the most probable root cause could be related to the surface finish on the elbow. There is a ¿mirror finish¿ on the surface of these elbows that should allow the mask to be removed easily; however the ¿mirror finish¿ may be promoting a suction-type seal between the mask and the bag disallowing it to be easily removed. Carefusion/bd has notified the assembly personnel of this failure and retrained them on the assembly method between the elbow and the mask ensuring the proper pressure is applied and proper technique is closely followed. As an additional corrective action to prevent this from re-occurring, the mold tool will be modified to eliminate the ¿mirror finish¿ condition on the components.
 
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Brand NameRESUS, ADLT W/MASK, 40" TBG, 6/CS
Type of DeviceMANUAL EMERGENCY VENTILATOR
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
jill rittorno
22745 savi ranch parkway
yorba linda, CA 92887
7149227830
MDR Report Key5987205
MDR Text Key55988822
Report Number8030673-2016-00236
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8005
Device Lot Number000956673
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/01/2016
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 Unkown

Patient Treatment Data
Date Received: 09/29/2016 Patient Sequence Number: 1
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