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U.S. Department of Health and Human Services

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

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CAREFUSION/BD RESUS, ADLT W/MASK, 40" TBG, 6/CS MANUAL EMERGENCY VENTILATOR Back to Search Results
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.
 
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Brand NameRESUS, ADLT W/MASK, 40" TBG, 6/CS
Type of DeviceMANUAL 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 Key6134844
MDR Text Key61142839
Report Number8030673-2016-00264
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
PMA/PMN Number
ENFORCEMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
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 Received11/30/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8005
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/23/2017
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 Treatment Data
Date Received: 11/30/2016 Patient Sequence Number: 1
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