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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 Failure (2484)
Event Date 09/01/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4) has received the complaint device and is currently performing an investigation into the reported issue. A follow up mdr will be sent once the investigation has been completed. (b)(4).
 
Event Description
The customer reported that it recently has become very difficult to remove mask from resuscitation bag. ¿mask seems very stuck and we have to really fight to force the mask off bag. It has been confirmed that during intubation the end-user had great difficulty disconnecting the face mask from the resuscitation bag after intubation¿. The customer is unsure if they had a delay in ventilation or if they were able to place the patient directly on the vent. It was confirmed that there was patient involvement with no harm.
 
Manufacturer Narrative
Device evaluation summary: one reprehensive sample from the same lot code was sent in for further evaluation. The unit was submitted to a functional inspection, and no issues related to this customers reported failure mode were found. Therefore this failure mode was not confirmed. A device history record review was also completed and no issues related to this reported failure mode were found. All aspects of the manufacturing process were evaluated for any possible contributing factors into this type of failure mode. Carefusion/bd concluded 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 Key6032244
MDR Text Key57553590
Report Number8030673-2016-00248
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
Type of Report Initial,Followup
Report Date 12/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8005
Device Lot Number0000934294
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/09/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2016
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 Initial

Patient Treatment Data
Date Received: 10/15/2016 Patient Sequence Number: 1
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