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 10820X10
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/06/2014
Event Type  Injury  
Event Description
It was reported by the patient that the sense lines had broken off of her patient circuits multiple times.In each case, the patient required manual ventilation.
 
Manufacturer Narrative
The customer provided photographs of the patient circuits and the location of the break.
 
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 Key4025497
MDR Text Key4877242
Report Number2031702-2014-00195
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 Consumer,Health Professional
Reporter Occupation Respiratory Therapist
Remedial Action Other
Type of Report Initial
Report Date 08/20/2014
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? No
Device Operator Other
Device Model Number10820X10
Device Catalogue Number10820X10
Other Device ID NumberRMA 245349
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 07/22/2014
Initial Date FDA Received08/20/2014
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
Patient Outcome(s) Life Threatening; Required Intervention;
-
-