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U.S. Department of Health and Human Services

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

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CAREFUSION/BD RESUS, INF W/MASK, RESV BAG, P/O, 6/CS MANUAL EMERGENCY VENTILATOR Back to Search Results
Catalog Number 2K8004
Device Problems Failure to Disconnect (2541); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)
Event Date 02/10/2017
Event Type  Injury  
Manufacturer Narrative
Upon complaint review and confirmation from the sales representative on 03/13/2017. The reported product code of 2k8021 was incorrect the product code is 2k8004. This complaint is a duplicate and will be closed. This reported incident for product code 2k8004 was submitted as an emdr on 03/10/2017, with a supplemental emdr on 04/21/2017.
 
Manufacturer Narrative
(b)(4) has reached out to customer three times to provide the complaint device for further investigation. A (b)(6) label was also provided to the customer each time. Unfortunately, (b)(4) has not received the complaint device for evaluation or the requested additional information. The end-user has not responded to email or phone messages. Analyst had been attempting to find out if this incident actually happened with this product code. The customer reported the exact same incident with a different product code. The sales rep stated "it is my understanding it was am adult bag which is why it wasn¿t more of an issue for them". We are conservatively reporting this incident as we are unable to verify this information with the end-user. If the sample or any additional information becomes available a follow up emdr will be submitted. (b)(4).
 
Event Description
Customer reported that the hospital is having issues. Staff is saying that it all has to do with them not being 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 rt's 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, INF W/MASK, RESV BAG, 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
mindy faber
75 n. fairway dr.
vernon hills, IL 60061
MDR Report Key6401182
MDR Text Key258951526
Report Number8030673-2017-00305
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 10/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2017
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 Received07/07/2017
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: 03/13/2017 Patient Sequence Number: 1
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