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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 01/11/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4) has reached out to customer to provide the complaint device for further investigation. At this time we are currently waiting for the sample. Once the investigation is complete or if we receive any additional information we will provide a follow up emdr. (b)(4).
 
Event Description
The customer reported that "they have not been able to disconnect the mask from the bag on their resus bags. " this reported incident involved a intubated patient in the ed.
 
Manufacturer Narrative
Follow up submission: two samples were received for evaluation. During inspection one of the resuscitators was disassembled at the mask and elbow, and the other could easily be detached from the mask and elbow. The failure reported was not confirmed. 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, 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 Key6313260
MDR Text Key66861482
Report Number8030673-2017-00280
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
Report Date 04/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2017
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 Manufacturer02/02/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2017
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: 02/08/2017 Patient Sequence Number: 1
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