MAUDE Adverse Event Report: CAREFUSION/BD 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 02/27/2017

Event Type  Injury  

Manufacturer Narrative

Customer advocacy has reached out to customer to provide sample for the investigation.Ups 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 reported ¿we could not remove the mask from the resus bag.The mask does not come off resuscitating bag - it is on very firm- even with "wiggling" the mask it is very hard to get off quickly.After mask bagging a patient prior to intubation, then patient is intubated and we go to bag/ breath for the patient, the mask does not come off.¿.

Manufacturer Narrative

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.(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 VENTILATOR
• Manufacturer (Section D): CAREFUSION/BD; cerrada vía de la producción; 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: 6447290
• MDR Text Key: 71300221
• Report Number: 8030673-2017-00309
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0001013505
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/30/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2017
• 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