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 No Consequences Or Impact To Patient (2199)

Event Date 09/06/2016

Event Type  Injury  

Manufacturer Narrative

It has been confirmed the complaint sample is not available for evaluation.Attempts have been made by customer advocacy to gain additional information from the customer and end user regarding situation reported with the device.Customer advocacy is still waiting for additional information regarding reported issue.If a sample or any additional information becomes available a follow up emdr will be submitted.(b)(4).

Event Description

The customer reported the following.You can't get the mask off of the resuscitation bag.This bag was not used because the end broke off in the mask collar and a new bag needed to be obtained."the respiratory therapist (rt) was attempting to ventilate a patient via an endotracheal tube (ett) post intubation.Luckily the rt was able to use the mechanical ventilator that was adjacent to the bed.The customer reported that there was no patient harm.

Manufacturer Narrative

Device evaluation summary: unfortunately the device was unavailable for further investigation.However a photo was submitted and the reported failure was confirmed off of this.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.

• 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: 6001717
• MDR Text Key: 56537264
• Report Number: 8030673-2016-00240
• 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: 10/05/2016
• 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: 0000944395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2016
• 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