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

Model Number LTV 1150

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 the ventilator alarmed or if it 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: 4338712
• MDR Text Key: 5200627
• Report Number: 2031702-2014-00267
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/17/2014

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 1150
• Device Catalogue Number: 18984-006
• Other Device ID Number: RMA 257726
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 11/21/2014
• Initial Date FDA Received: 12/17/2014
• Date Device Manufactured: 06/30/2011
• 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