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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 02/10/2017
Event Type  Injury  
Manufacturer Narrative
Carefusion has received the complaint device and is currently performing an investigation into the reported issue. A supplemental emdr will be sent once the investigation has been completed. (b)(4).
 
Event Description
The customer reported the following to the vyaire sales representative. "the mask is difficult to remove post intubation when attempting to ventilate via endotracheal tube".
 
Manufacturer Narrative
Follow up submission: one sample was received for evaluation. During inspection it was observed that the resuscitator was returned disassembled, the failure mode could not be 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 rcmx509. 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
mindy faber
75 n. fairway dr.
vernon hills, IL 60061
MDR Report Key6375979
MDR Text Key69011514
Report Number8030673-2017-00287
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 Received03/03/2017
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 Manufacturer03/07/2017
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? 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

Patient Treatment Data
Date Received: 03/03/2017 Patient Sequence Number: 1
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