MAUDE Adverse Event Report: CAREFUSION, INC RESUS, ADLT W/MASK, 40" TBG, 6/CS; CARDIOPULMONARY RESUSCITATION AID KIT

Model Number 2K8005

Device Problem Failure to Disconnect (2541)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2016

Event Type  Injury  

Manufacturer Narrative

At this time we are awaiting the return of the device from the customer.The customer has been provided a shipping label.If any additional information becomes available a supplemental report will be filed.(b)(4).

Event Description

Customer reported ¿while rt staff responded to a code blue situation of a non intubated patient were able to bag patient without incident however as patient had an airway (ett) established therapist was unable to remove mask to apply the 15ml adapter.There was no patient harm to this patient but there was a minor delay in ventilating the patient while a new bag was gathered.The mask was very difficult to remove, but after the patient was stabilized we messed around with the bag again and eventually after multiple people tried we were able to remove the mask from the bag.

Manufacturer Narrative

Follow up submission investigation results: one opened sample was received for evaluation.The unit was submitted to a functional inspection in accordance to procedure and no issues related to the customer report were found.The device history record was reviewed for the lot number reported and no issues were found.Despite that the product sample did not present the issue reported.Based on similar reports a probable root cause is related to the current mirror finish on the surface of the elbow connector.This mirror finish can make it difficult to remove the mask from the component.The elbow connector will now have a brushed surface to allow for the mask to be removed easily.A capa was initiated to further investigate this issue.

• Brand Name: RESUS, ADLT W/MASK, 40" TBG, 6/CS
• Type of Device: CARDIOPULMONARY RESUSCITATION AID KIT
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; cerrada vía de la producción; no. 85., parque industrial mex; mexicali baja california norte ; MX
• Manufacturer Contact: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6120891
• MDR Text Key: 60685490
• Report Number: 8030673-2016-00260
• 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: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2K8005
• Device Lot Number: 0000979971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention