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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION/BD SELF-INFLATING RESUSCITATION BAG MANUAL EMERGENCY VENTILATOR

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CAREFUSION/BD SELF-INFLATING RESUSCITATION BAG MANUAL EMERGENCY VENTILATOR Back to Search Results
Model Number ADULT, WITH MASK, OXYGEN RESERVOIR BAG, PEEP VALVE
Device Problem Failure to Disconnect (2541)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/31/2017
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 "during an emergent intervention, initial end-user reported mask attached to bag was very difficult to detach after patient was intubated and needed direct ventilation/oxygenation. Two other clinicians (male/female) attempted to detach mask, but were unable to". Another resuscitation bag was retrieved and no issues were found with it. "total delay time was 10-15 seconds. " customer reported that there was no patient injury.
 
Manufacturer Narrative
Follow up submission: one sample was returned for evaluation. During inspection the mask was able to be removed from the resuscitator without any issues. This sample did not exhibit the difficult to detach condition between the elbow and mask. At this time we are unable to confirm the reported issue off of the sample received. 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 NameSELF-INFLATING RESUSCITATION BAG
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 Key6367082
MDR Text Key68598106
Report Number8030673-2017-00286
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 Received02/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberADULT, WITH MASK, OXYGEN RESERVOIR BAG, PEEP VALVE
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 Received04/20/2017
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: 02/28/2017 Patient Sequence Number: 1
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