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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 Problems Air Leak (1008); Failure To Adhere Or Bond (1031)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/22/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Results of investigation: one sample was submitted to (b)(4) for evaluation and per the visual inspection no issues were found. The sample was also submitted to a functional inspection. This included an evaluation of the solvent effectiveness with a pull test. We confirmed a lack of solvent; this was observed between the pvc tubing and the threaded o2 housing. It is considered that this insufficiency of solvent between these two components could provoke the leak found in the resuscitator; therefore the failure mode reported was confirmed. Based on this investigation the root cause was found to be related to personnel not following procedure. Personnel missed applying the methyl methylene chloride (mek) between the pvc tubing and the housing causing an incomplete assembly of this product. For corrective and preventative action the personnel have been retrained on applying mek per the written manufacturing procedure.
 
Event Description
Customer reported the following: ¿i have one of the adult bags here with an air leak. When a seal is tried to be made over the patient, the bag leaks elsewhere, it did not ventilate properly. A new bag was required to continue. It was confirmed that no harm was caused to the patient. The pacu director said the leakage occurred around the valve. There was no visible damage to the bag¿.
 
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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
jill rittorno
22745 savi ranch parkway
yorba linda, CA 92887
MDR Report Key6061166
MDR Text Key58528714
Report Number8030673-2016-00254
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 Other Health Care Professional
Type of Report Initial
Report Date 10/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8004
Device Lot Number0000859208
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2016
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

Patient Treatment Data
Date Received: 10/27/2016 Patient Sequence Number: 1
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