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

Catalog Number 2K8005

Device Problem Failure to Disconnect (2541)

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

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

It has been confirmed by carefusion/bd that 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 the situation reported with the device.If a sample or any additional information becomes available a follow up emdr will be submitted.(b)(4).

Event Description

Customer reported customer ¿we could not remove the mask from the resus bag".The respiratory therapist has had this issue during an emergency intubation.

Manufacturer Narrative

Follow up submission: no sample was provided for evaluation.At this time we are unable to confirm the reported issue.However, based on similar complaint investigations, a probable root cause is related to the current mirror finish surface on the elbow, which makes the mask very difficult to remove.Capa was opened to further investigate this issue.Capa (b)(4).The elbow will now contain a textured finish to allow the mask to be easily removed from the elbow.

• Brand Name: RESUS, ADLT W/MASK, 40" TBG, 6/CS
• Type of Device: MANUAL EMERGENCY VENTILATORMANUAL EMERGENCY VENTILATOR
• Manufacturer (Section D): CAREFUSION/BD; 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: mindy faber ; 75 north fairway drive; vernon hills, IL 60061
• MDR Report Key: 6447344
• MDR Text Key: 71301126
• Report Number: 8030673-2017-00314
• 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: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2K8005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention