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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 12/07/2016
Event Type  Injury  
Manufacturer Narrative
Carefusion has reached out to customer to provide the complaint device for further investigation. The customer indicated that the sample involved in the incident is not available, and was disposed of. The customer will provide a representative sample. A ups label was provided to the customer. A follow up mdr will be sent once the investigation has been completed. (b)(4).
 
Event Description
Customer reported that the masks on their resuscitation bags will not come off the elbow. ¿the patient was mask bagged and then the anesthetist placed an ett in the airway but the mask would not detach from the resuscitation bag elbow". It was stated there have been no injuries, or death related to this issue "the defective sample was tossed because it was used on a the patient".
 
Manufacturer Narrative
Follow up submission: a representative sample was received for evaluation; however the sample did not exhibit the difficult to remove condition of the mask from the elbow. 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, 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 Key6213798
MDR Text Key63563767
Report Number8030673-2016-00274
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 04/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8005
Device Lot Number0000975502
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2017
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: 12/29/2016 Patient Sequence Number: 1
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