Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 203, INC LTV PATIENT CIRCUIT; CIRCUIT, BREATHING
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CAREFUSION 203, INC LTV PATIENT CIRCUIT; CIRCUIT, BREATHING Back to Search Results
Model Number 15091-104
Device Problems Hole In Material (1293); Leak/Splash (1354); Melted (1385); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
It was reported that the ventilator had alarmed for disc/sense and there was a leak in the patient circuit.The leak was due to a hole that had melted in the plastic of the heated wire circuit.The patient circuit was changed with no patient harm reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LTV PATIENT CIRCUIT
Type of Device
CIRCUIT, BREATHING
Manufacturer (Section D)
CAREFUSION 203, INC
17400 medina road
suite 100
plymouth MN 55447
Manufacturer (Section G)
CAREFUSION 203, INC
17400 medina road
suite 100
plymouth MN 55447
Manufacturer Contact
jennifer huybrecht
7633988395
MDR Report Key4178767
MDR Text Key5157828
Report Number2031702-2014-00224
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial
Report Date 10/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Patient Family Member or Friend
Device Model Number15091-104
Device Catalogue Number15091-104
Device Lot Number0000694733
Other Device ID NumberRMA 251006
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/02/2014
Is the Reporter a Health Professional? Yes
Event Location Other
Date Manufacturer Received09/16/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2000
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-