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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC RESUS, ADLT W/MASK, LRG TBG, 6/CS MANUAL EMERGENCY VENTILATOR

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CAREFUSION, INC RESUS, ADLT W/MASK, LRG TBG, 6/CS MANUAL EMERGENCY VENTILATOR Back to Search Results
Model Number 2K8017
Device Problem Break (1069)
Patient Problems Death (1802); Respiratory Distress (2045)
Event Date 05/04/2016
Event Type  Death  
Manufacturer Narrative
(b)(4)- carefusion received this complaint via (b)(4)). The customer has been contacted by carefusion via email and phone. The customer stated via email the used sample will not be returned to carefusion, but is available on site at their facility. Carefusion requested a photograph to be provided to understand the failure described. At this time carefusion is currently waiting to receive the photo. Customer stated that once the defective product was changed to a new device, there were no further airway management issues. However, the customer stated the patient has expired at this time; date of death is unknown at this time by carefusion. This device was being used during a "cardiac event" when the failure was detected. Carefusion is currently awaiting further information from the customer, including a photo of the defective device. Carefusion will submit a follow up report if any further information is received. (b)(4).
 
Event Description
(b)(4) states: "during a cardiac event it was noted by rt managing the airway that the bag resuscitator did not have oxygen flow out when bag was manually squeezed. It appears the valve at the distal end of the equipment was broken or defective. When the product was switched out there were not further airway management issues". Further information obtained, customer stated "the sample has been retained by the hospital and can be reviewed on-site. Unsure if there was any patient harm. Patient is deceased. The rt was alerted by the following, after a couple breaths realized something was wrong with the resuscitator and no etc02 reading was noted".
 
Manufacturer Narrative
(b)(4) follow up emdr submission. Customer advocacy has reached out to the customer multiple times via phone and email to gain additional information. A photo was requested from the customer so that customer advocacy could determine where the failure occurred on the device. However, the customer did not provide a photo of the defect reported. Investigation results: unfortunately the sample or a photo was not provided or available for evaluation. The failure mode reported at this time cannot be confirmed. The device history record for the lot reported was evaluated for any issues related with this customer report and no issues were found. The product was manufactured, inspected and released in accordance with our internal procedures. Two years of complaints were reviewed from august 1, 2014 - july 31, 2016 and no trend was detected. Without sample available for evaluation it¿s unable to determine if personnel contributed to this failure. The current product line is running according to procedure. In addition, our quality personnel routinely check the product visually and functionally to assess for any defects or issues. Based on the investigation, at this time it¿s not possible to determine a root cause for the issue reported on product since the sample was not available for evaluation. At this time no corrective action will be implemented, since the defect could not be confirmed. (b)(4).
 
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Brand NameRESUS, ADLT W/MASK, LRG TBG, 6/CS
Type of DeviceMANUAL EMERGENCY VENTILATOR
Manufacturer (Section D)
CAREFUSION, INC
75 north fairway drive
vernon hills IL 60061
Manufacturer (Section G)
CAREFUSION, INC
cerrada vía de la producción
no. 85., parque industrial mex
mexicali baja california norte
MX
Manufacturer Contact
jill rittorno
22745 savi ranch parkway
yorba linda, CA 92887
MDR Report Key5775783
MDR Text Key48977916
Report Number8030673-2016-00179
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 06/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2K8017
Device Lot Number0000859202
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 Received08/12/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 07/07/2016 Patient Sequence Number: 1
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