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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION/BD RESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS MANUAL EMERGENCY VENTILATOR

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CAREFUSION/BD RESUS,ADLT W/MSK,LRG TBG, P/O, 6/CS MANUAL EMERGENCY VENTILATOR Back to Search Results
Catalog Number 2K8032
Device Problem Air Leak (1008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/19/2017
Event Type  Injury  
Manufacturer Narrative
One opened sample was received for evaluation. A leak test was performed and the device failed the leak test. The leak was present at the blue balloon. A lack of uv glue was observed at this area causing the reported leak. A dhr review was conducted and no issues were found. 2-years of complaints were reviewed and no trend was detected relating to this issue. The probable root cause of this issue is related to process/method error due to inconsistent uv glue application and the failure of personnel to perform the 100% post curing inspection as described in the procedure. A capa (b)(4) was implemented relating to this issue. Corrective actions performed: uv glue dispensing system changed, operators were certified to apply the adhesive, personnel were retrained in 100% post curing inspection, preventative maintenance was updated to include monthly inspection of the uv device glass with bulb replacement every 3 months.
 
Manufacturer Narrative
Customer advocacy has reached out to customer to provide sample for the investigation. Ups label was provided to the customer. At this time we are currently waiting for the sample. Once the investigation is complete or if we receive any additional information we will provide a follow up emdr. (b)(4).
 
Event Description
Customer reported "air leak on valve when used on a patient, there was no patient harm. The end-user noticed an air leak on the bag and it does not provide full ventilation to the patient during intubation. They used a new resuscitation bag to complete the procedure since they noticed instantly that there was an air leak and the bag could not provide full ventilation to the patient".
 
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Brand NameRESUS,ADLT W/MSK,LRG TBG, 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 north fairway drive
vernon hills, IL 60061
MDR Report Key6457343
MDR Text Key110216980
Report Number8030673-2017-00316
Device Sequence Number1
Product Code OEV
Combination Product (y/n)N
Reporter Country CodeRP
PMA/PMN Number
ENFORCEMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2K8032
Device Lot Number0000816138
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/04/2017
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: 04/04/2017 Patient Sequence Number: 1
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