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

Catalog Number 2K8005

Device Problem Failure to Disconnect (2541)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/04/2016

Event Type  Injury  

Manufacturer Narrative

Carefusion has reached out to customer to provide the complaint device for further investigation.(b)(6) label was provided to the customer.At this time we are currently waiting for the sample.Once the investigation is complete or if we receive any additional information we will provide a follow up emdr.(b)(4).

Event Description

Customer verbally stated via telephone that they cannot get the mask off the bag without prying.It was confirmed that there was patient involvement, harm is unknown.

Manufacturer Narrative

Device evaluation: unfortunately the unit was not available for evaluation so the reported failure could not be confirmed.Based on similar complaints 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, INC; cerrada vía de la producción; no. 85 parque industrial; mexicali baja california norte
• Manufacturer (Section G): CAREFUSION, INC; 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
• MDR Report Key: 6071481
• MDR Text Key: 58919696
• Report Number: 8030673-2016-00255
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• 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: 0000963256
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention