MAUDE Adverse Event Report: CAREFUSION/BD RESUS, ADLT W/MASK, 40" TBG, 6/CS; MANUAL EMERGENCY VENTILATOR

Catalog Number 2K8005

Device Problem Failure to Disconnect (2541)

Patient Problem Respiratory Failure (2484)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

Carefusion 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 reported 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.(b)(4) 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.(b)(4) 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.

• Brand Name: RESUS, ADLT W/MASK, 40" TBG, 6/CS
• Type of Device: MANUAL 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 Key: 6032139
• MDR Text Key: 57553704
• Report Number: 8030673-2016-00249
• Device Sequence Number: 1
• Product Code: OEV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: ENFORCEMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• 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 Received: 10/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2K8005
• Device Lot Number: 0000934294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention