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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC MANUAL EMERGENCY VENTILATOR

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CAREFUSION, INC MANUAL EMERGENCY VENTILATOR Back to Search Results
Device Problem Detachment Of Device Component (1104)
Patient Problem Hypoxia (1918)
Event Date 07/29/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). Initial emdr submission. At this time, the customer has not responded to requests for additional information regarding this event. If additional information becomes available, it will be submitted in a follow up report. (b)(4). At this time, carefusion has not received the suspect device/component for evaluation.
 
Event Description
¿patient oxygen saturation and respirations decreased, ambu bag used to assist patient. Air reservoir bag did not inflate at all, seal at base not present. Space pinched until another ambu bag obtained. Saturation levels increased once the broken seal was pinched, and with new bag. No harm to patient. The staff member indicated that the distal end of the air reservoir bag, where the tubing comes through the bag, was not sealed. There was an increase in oxygen saturation once a new bag with the seal intact was obtained. The number on the exhalation port is (b)(4). These are the only numbers on the device. ¿.
 
Manufacturer Narrative
Follow up submission: carefusion has made multiple attempts to gain the product code and lot number from the customer. On (b)(6) 2016, customer confirmed device is not in their possession. In addition, part number and lot number are unknown. For this reason we are unable to further evaluate the issue reported. Should the device or product information become available an investigation will be completed.
 
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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 Key5953289
MDR Text Key54829000
Report Number8030673-2016-00230
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,other,use
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/24/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received10/19/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/15/2016 Patient Sequence Number: 1
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