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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION FLOW-INFLATING BAG 1L; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
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CAREFUSION FLOW-INFLATING BAG 1L; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) Back to Search Results
Model Number 2K8027
Device Problems Disconnection (1171); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/06/2014
Event Type  malfunction  
Event Description
Customer reported: the green bag pops off of the white plastic piece.Patient was being actively bagged when the bag fell apart.Replacement bag had to be used.No adverse events reported.
 
Manufacturer Narrative
(b)(4).Device evaluation anticipated but has not yet begun.Upon carefusion's investigation, a follow up medwatch will be submitted.
 
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Brand Name
FLOW-INFLATING BAG 1L
Type of Device
VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
Manufacturer (Section D)
CAREFUSION
75 north fairway drive
vernon hills IL 60061
Manufacturer (Section G)
PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V
cerrada via de la produccion
no85parque indust.mexicali iii
mexicali 21600
MX   21600
Manufacturer Contact
jill rittorno
75 north fairway drive
vernon hills, IL 60061
8473628056
MDR Report Key3623965
MDR Text Key4174501
Report Number8030673-2014-00098
Device Sequence Number1
Product Code BTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K932557
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 01/14/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2K8027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received01/14/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
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