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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CAREFUSION; VENTILATOR, HIGH FREQUENCY
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CAREFUSION CAREFUSION; VENTILATOR, HIGH FREQUENCY Back to Search Results
Model Number 3100A
Device Problem Moisture or Humidity Problem (2986)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/30/2015
Event Type  malfunction  
Event Description
The customer reported that with the new style cap/diaphragms they are seeing water on the blue line.The ventilator was on a patient, the patient was removed from the ventilator and placed on another.No patient harm.
 
Manufacturer Narrative
The carefusion field service engineer evaluated the ventilator and found no evidence of liquid in any lines, no abnormal noise heard.Verified performance, passed all performance checks.(b)(4).
 
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Brand Name
CAREFUSION
Type of Device
VENTILATOR, HIGH FREQUENCY
Manufacturer (Section D)
CAREFUSION
yorba linda CA
Manufacturer (Section G)
VIASYS RESPIRATORY CARE INC
1100 bird center dr.
palm springs CA 92262
Manufacturer Contact
jill rittorno
75 n. fairway dr.
vernon hills, IL 60061
8473628056
MDR Report Key4961461
MDR Text Key6255547
Report Number2021710-2015-01276
Device Sequence Number1
Product Code LSZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P890057
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Health Professional
Type of Report Initial
Report Date 06/30/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3100A
Device Catalogue Number768901
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/30/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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