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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION; VENTILATOR, NON-CONTINUOUS

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CAREFUSION INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION; VENTILATOR, NON-CONTINUOUS 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 12/27/2014
Event Type  malfunction  
Event Description
The customer reported that the display of sipap was power down suddenly during use to the pt.It was black and did not display with nothing.The using mode is ncpap and this unit was used 20 hours for the pt.The alarm sound and message were not confirmed in the hosp.Because the air/o2 gases were supplied normally, there was no health hazard to the pt.
 
Manufacturer Narrative
(b)(4).The customer evaluated the ventilator and determined that replacement of the battery fixed the reported issue.
 
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Brand Name
INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
Type of Device
VENTILATOR, NON-CONTINUOUS
Manufacturer (Section D)
CAREFUSION
yorba linda CA
Manufacturer (Section G)
CAREFUSION
1100 bird center dr.
palm springs CA 92262
Manufacturer Contact
jill rittorno
22745 savi ranch parkway
yorba linda, CA 92887
7607787219
MDR Report Key4548186
MDR Text Key5511476
Report Number2021710-2015-00338
Device Sequence Number1
Product Code BZD
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K031745
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor,distributor,foreign
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 01/20/2015
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-012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/20/2015
Initial Date FDA Received02/19/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2013
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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