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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 Pressure Problem (3012)
Patient Problem Hyperglycemia (1905)
Event Date 12/09/2014
Event Type  malfunction  
Manufacturer Narrative
This medwatch report was identified as a late submission during a two year retrospective review of complaints and mdr¿s following receipt of an untitled letter issued by the fda.As of this date the device has not been received for evaluation.When it has been received and evaluated a supplement will be filed.
 
Event Description
The following description of the event was received via an email from carefusion (b)(4) on (b)(6) 2014.Carefusion (b)(4) reported that the cap diaphragms failed to pressurize while the vent was on a patient.The hf-ov would not reach pressure as advised on set up.There was no harm to the patient.
 
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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
marshall thompson
7607787307
MDR Report Key5427756
MDR Text Key38228503
Report Number2021710-2016-03115
Device Sequence Number1
Product Code LSZ
Combination Product (y/n)N
Reporter Country CodeUK
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 12/09/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3100A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/09/2015
Initial Date FDA Received02/10/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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