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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 3100B
Device Problems Failure to Power Up (1476); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/03/2014
Event Type  malfunction  
Manufacturer Narrative
The unit was returned to carefusiuon for repair and evaluation.It was not possible to duplicate the issue as reported by the carefusion fse.A pm was performed and the unit was operating as per specification and returned to the customer.
 
Event Description
The following description of the event was received from carefusion fse on (b)(6) 2014 the carefusion fse reported that this unit seems to start intermittently.He said that the unit seemed to pass the spi but towards the end the unit wouldn't start when he hit the start stop button.He said he also got it started then it stopped out of the blue.
 
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Brand Name
CAREFUSION
Type of Device
VENTILATOR, HIGH FREQUENCY
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
marshalll thompson
7607787307
MDR Report Key5414637
MDR Text Key38140929
Report Number2021710-2016-02862
Device Sequence Number1
Product Code LSZ
Combination Product (y/n)N
PMA/PMN Number
P890057
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Health Professional
Type of Report Initial
Report Date 02/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3100B
Device Catalogue Number773967-RNT
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/12/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2002
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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