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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION/BD RESUS, ADLT W/MASK, RSV BAG, PEEP 6/CS MANUAL EMERGENCY VENTILATOR

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CAREFUSION/BD RESUS, ADLT W/MASK, RSV BAG, PEEP 6/CS MANUAL EMERGENCY VENTILATOR Back to Search Results
Catalog Number 2K8035
Device Problem Failure to Disconnect (2541)
Patient Problem Cardiopulmonary Arrest (1765)
Event Date 01/10/2017
Event Type  Injury  
Manufacturer Narrative
It has been confirmed the complaint sample is not available for evaluation. Attempts have been made by customer advocacy to gain additional information from the customer and end user regarding situation reported with the device. Customer advocacy is still waiting for additional information regarding reported issue. If a sample or any additional information becomes available a follow up emdr will be submitted. (b)(4).
 
Event Description
The customer reported that the "physician had to do mouth to ett resuscitation due to the fact nobody could get the mask off the resus bag. ".
 
Manufacturer Narrative
Follow up submission: 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. Capa (b)(4). The elbow will now contain a textured finish to allow the mask to be easily removed from the elbow.
 
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Brand NameRESUS, ADLT W/MASK, RSV BAG, PEEP 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 Key6265079
MDR Text Key65345274
Report Number8030673-2017-00276
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8035
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2017
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 Unkown

Patient Treatment Data
Date Received: 01/19/2017 Patient Sequence Number: 1
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