MAUDE Adverse Event Report: CAREFUSION CORPORATION LTV 1200; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number 18881-001

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2017

Event Type  malfunction  

Event Description

Patient was being moved from mri gantry to mri-safe stretcher and staff member moved the ventilator closer to the mri gantry to assist in patient transfer when the ventilator moved and stuck to the side of mri bore.

• Brand Name: LTV 1200
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): CAREFUSION CORPORATION; 1100 bird center dr.; palm springs CA 92262
• MDR Report Key: 7120445
• MDR Text Key: 94956888
• Report Number: 7120445
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 18881-001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/13/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: MRI UNIT
• Patient Age: 49 YR