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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 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.
 
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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 Key6177013
MDR Text Key62544236
Report Number8030673-2016-00269
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
ENFORCEMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
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 Received12/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8005
Device Lot Number0000970278
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2017
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 Treatment Data
Date Received: 12/15/2016 Patient Sequence Number: 1
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