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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CAREFUSION; MIXER, BREATHING GASES, ANESTHESIA INHALATION
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CAREFUSION CAREFUSION; MIXER, BREATHING GASES, ANESTHESIA INHALATION Back to Search Results
Model Number MICROBLENDER
Device Problem Inaccurate Delivery (2339)
Patient Problem No Patient Involvement (2645)
Event Date 09/10/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The carefusion factory service and failure analysis technicians evaluated the device and were unable to duplicate the reported complaint.The customer was operating the device at 2 lpm which is outside of the designed range of 3 lpm to 30 lpm.
 
Event Description
The customer reported that the blender fio2 readings are off.No patient involvement.
 
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Brand Name
CAREFUSION
Type of Device
MIXER, BREATHING GASES, ANESTHESIA INHALATION
Manufacturer (Section D)
CAREFUSION
22745 savi ranch parkway
yorba linda CA 92887
Manufacturer (Section G)
CAREFUSION
1100 bird center drive
palm springs CA 92262
Manufacturer Contact
jill rittorno
75 n. fairway drive
vernon hills, IL 
8473628056
MDR Report Key5117901
MDR Text Key27482201
Report Number2021710-2015-01856
Device Sequence Number1
Product Code BZR
Combination Product (y/n)N
PMA/PMN Number
K883038
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Health Professional
Report Date 09/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMICROBLENDER
Device Catalogue Number10065
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/10/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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