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

Catalog Number 2K8005

Device Problem Difficult to Remove (1528)

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

Event Date 01/03/2017

Event Type  Injury  

Manufacturer Narrative

Initial emdr submission: multiple attempts have been made to the customer to gain the sample and additional information regarding the patient involved.If any additional information becomes available, a supplemental submission will be filed.

Event Description

The mask on the ambu-bag cannot be removed during a code.It seems the ambu-bags with the yellowish mask are the ones that cannot be removed.Reported item was being used on patient.Patient harm or medical intervention unknown at this time.

Manufacturer Narrative

Follow up submission: six unopened samples were received for evaluation with lot number 0001002018.The units were submitted to a functional inspection and only one of the samples was unable to disconnect the mask from the resus bag.The manufacturing process was reviewed.Based on the investigation the root cause is considered to be related to the current mirror like surface on the elbow, part number 12276939, which makes the mask very difficult to remove.To correct this issue, the elbow will now contain a brushed surface which will allow the mask to be removed easily.(b)(4).

• 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: 6272877
• MDR Text Key: 65604466
• Report Number: 8030673-2017-00277
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2017
• 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: 0001002018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention