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

Catalog Number 2K8005

Device Problems Break (1069); Sticking (1597); Failure to Disconnect (2541)

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

Event Date 11/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Carefusion/bd has reached out to customer to provide the complaint device for further investigation.The customer indicated that the sample was shipped back to carefusion/bd.A follow up mdr will be sent once the investigation has been completed.(b)(4).

Event Description

The customer reported that the resuscitation bags attachment piece to the mask broke off and stuck on the mask."the failure occurred following intubation of a patient with the inability to remove the mask from the connector to the resuscitation bag.Immediate harm to the patient was avoided with the quick response of the respiratory therapist who was able to connect the patient to the ventilator and deliver volume and oxygen to the patient without life threatening delay.When the connector to the resuscitation bag broke off there was no way to connect the resuscitation bag to the endotracheal tube.The mask and where the mask attaches to the resuscitation bag were intact".

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.A capa was initiated to investigate the root cause further.The elbow will be updated to contain a brushed surface to prevent the two components from getting stuck.

• 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: 6134844
• MDR Text Key: 61142839
• Report Number: 8030673-2016-00264
• Device Sequence Number: 1
• Product Code: OEV
• Combination Product (y/n): N
• PMA/PMN Number: ENFORCEMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2017
• 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