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 11/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported "we are having difficulty removing the masks when attempting to connect the bags directly to the patients et tube.This is causing an unnecessary, dangerous delay in ventilating critically ill patients.Customer reported no patient harm or medical intervention was required".

Manufacturer Narrative

Customer provided additional information.It has been confirmed that this device was not used on a patient.This device was found pre-use in the customers self stock.This incident is not considered reportable with this additional information.If we receive any additional information that would make this incident reportable we will provide a follow up emdr.

Manufacturer Narrative

A sample was received for evaluation.The sample was tested functionally and no issues related to this customer report were found.Even though the complaint was not confirmed in the samples received.Based on similar reports and investigations, a probable root cause considered is related to the mirror like finish on the surface of the elbow connector.This mirror like finish can make the mask very difficult to remove.The elbow will be updated to contain a brushed surface to prevent the two components from getting stuck.A capa was initiated to further determine the root cause.

• 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: jill rittorno ; 22745 savi ranch parkway; yorba linda, CA 92887
• MDR Report Key: 6177013
• MDR Text Key: 62544236
• Report Number: 8030673-2016-00269
• 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,Followup
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• 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: 0000970278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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