MAUDE Adverse Event Report: CAREFUSION 203, INC LTV; VENTILATOR, CONTINUOUS

Model Number LTV 1200

Device Problem Sticking (1597)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported that the ventilator's turbine did not rotate.It is unknown if there was an audible alarm or if the ventilator was connected to a patient when the reported problem occurred.

• Brand Name: LTV
• Type of Device: VENTILATOR, CONTINUOUS
• 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 Key: 3782265
• MDR Text Key: 4379406
• Report Number: 2031702-2014-00109
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K060647
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/30/2014

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: Other
• Device Model Number: LTV 1200
• Device Catalogue Number: 18888-006
• Other Device ID Number: RMA 234976
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2014
• Event Location: Other
• Initial Date Manufacturer Received: 03/31/2014
• Initial Date FDA Received: 04/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1