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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CAREFUSION; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
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CAREFUSION CAREFUSION; VENTILATOR, NON-CONTINUOUS (RESPIRATOR) Back to Search Results
Model Number SIPAP
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/26/2015
Event Type  malfunction  
Event Description
The customer reported that while in patient use the unit will not read the high pressure but reads the low pressure.The patient removed from the unit and replaced on another sipap unit, no patient harm.
 
Manufacturer Narrative
(b)(4).The carefusion factory service technician evaluated the device and was unable to duplicate the customer reported complaint.The carefusion failure analysis technician agreed with these findings.See scanned page.
 
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Brand Name
CAREFUSION
Type of Device
VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
Manufacturer (Section D)
CAREFUSION
yorba linda CA
Manufacturer (Section G)
CAREFUSION
1100 bird center dr.
palm springs CA 92262
Manufacturer Contact
wendy schumacher
7607787219
MDR Report Key4576555
MDR Text Key16081212
Report Number2021710-2015-00381
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031745
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 01/26/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSIPAP
Device Catalogue Number675-CFG-005
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/05/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/26/2015
Initial Date FDA Received02/25/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2014
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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