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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION/BD RESUS, ADLT W/MASK, RESV BAG, 6/CS MANUAL EMERGENCY VENTILATOR

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CAREFUSION/BD RESUS, ADLT W/MASK, RESV BAG, 6/CS MANUAL EMERGENCY VENTILATOR Back to Search Results
Catalog Number 2K8004
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
Corrected data: this complaint was re-evaluated during a complaint review. The roi has been revised to reflect the following corrected information. The failure mode reported was for the resuscitation bag elbow not disconnecting from an endotracheal tube. The capa referenced prior is not related to this reported failure mode. Unfortunately as stated prior vyaire did not receive a sample for a thorough evaluation; therefore the unable to disconnect failure mode could not be confirmed. Two years of complaint trends were reviewed and no trend was identified. At this time, no corrective actions will be implemented.
 
Manufacturer Narrative
It has been confirmed by carefusion/bd that the complaint sample is not available for evaluation. Attempts have been made by customer advocacy to gain additional information from the customer and end user regarding the situation reported with the device. Customer advocacy is still waiting for additional information regarding reported issue. If a sample or any additional information becomes available a follow up emdr will be submitted. (b)(4).
 
Event Description
Customer reported that the staff is not able to detach the mask from the bag. ¿this has happened a few times to us at (b)(6). It is random, and has not caused any patient problems. I assumed someone had pushed the mask too far on to the bag and i wasn't strong enough to get it apart. One tech said that he had trouble disconnecting the bag from the endotracheal tube the end of the tube came apart when the bag was removed. Luckily there was a couple extra respiratory therapists there that fixed the issue very quickly¿.
 
Manufacturer Narrative
The following information should be removed from this report. "the staff is not able to detach the mask from the bag. ¿this has happened a few times to us at (b)(6). It is random, and has not caused any patient problems. I assumed someone had pushed the mask too far on to the bag and i wasn't strong enough to get it apart". This information is reflected in a different complaint. Customer advocacy is still waiting for additional information regarding reported issue. If a sample or any additional information becomes available a follow up emdr will be submitted.
 
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/MASK, RESV BAG, 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 Key6397878
MDR Text Key109540751
Report Number8030673-2017-00303
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,Followup,Followup
Report Date 11/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8004
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 Received10/27/2017
Was Device Evaluated by Manufacturer? No
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: 03/11/2017 Patient Sequence Number: 1
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