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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION/BD RESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS MANUAL EMERGENCY VENTILATOR

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CAREFUSION/BD RESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS MANUAL EMERGENCY VENTILATOR Back to Search Results
Catalog Number 2K8032
Device Problem Failure to Disconnect (2541)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/28/2016
Event Type  Injury  
Manufacturer Narrative
Carefusion has reached out to the customer three times to provide the complaint device for further investigation and to obtain additional information. Unfortunately, carefusion/bd never received the complaint device for evaluation or the requested information. If a sample or any additional information becomes available a follow up emdr will be submitted. The sales representative did verify that "the in-use instance was not with an intubated patient". Per the sales representative "the customer has not documented any patient incidents". Carefusion has opted to conservatively report one instance due to the lack of response and information from the end-user. (b)(4).
 
Event Description
The customer reported the following information. "the problem is removing the mask off of the ambu bag. We need to attach the ambu bag to an et tube. We can't. This is huge for us. When we need to transport an intubated patient we can't keep opening ambu bags to see if we can get the mask off. ¿.
 
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/MSK,LRG TBG, P/O, 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 Key6325055
MDR Text Key67209663
Report Number8030673-2017-00281
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 Received02/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8032
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? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/13/2017 Patient Sequence Number: 1
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