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

Catalog Number 2K8005

Device Problems Failure to Disconnect (2541); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2016

Event Type  Injury  

Manufacturer Narrative

At this time, the customer stated that no additional information is available.If additional information becomes available, it will be submitted in a follow up report.(b)(4).At this time, no sample is available.

Event Description

After patient was intubated, staff attempted to remove mask from ambu bag.Ambu bag would not disconnect from mask.When another staff member was finally able to pull apart it came apart at wrong area causing the bvm to be broken/unusable.Patient was quickly placed on vent and bilateral breath sounds were heard.

Manufacturer Narrative

Follow up emdr submission, investigation results: a sample was not provided for evaluation.However based on similar investigations the probably root cause is the mirror like finish on the elbow with part number 12276939 can make the mask very difficult to remove by creating suction like affect between the two components.To correct this issue the elbow will now have a brushed finished surface which will allow the mask to be removed easily.A capa has been opened to further investigate the root cause of the failure reported.

• 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: 6074141
• MDR Text Key: 59010860
• Report Number: 8030673-2016-00256
• 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,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2016
• 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: 944395
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention