MAUDE Adverse Event Report: CAREFUSION 2200, INC. AIRLIFE; VENTILATOR BREATHING CIRCUIT

Catalog Number RT509-852

Device Problems Hole In Material (1293); Melted (1385)

Patient Problem No Information (3190)

Event Date 08/03/2015

Event Type  malfunction  

Event Description

The staff went to reposition the ventilator circuit and it ripped a hole in the expiratory limb.The hole was caused by the circuit melting the temp probe wire and it came apart when moved.We have seen this type of event before.

• Brand Name: AIRLIFE
• Type of Device: VENTILATOR BREATHING CIRCUIT
• Manufacturer (Section D): CAREFUSION 2200, INC.; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 5060203
• MDR Text Key: 25118453
• Report Number: 5060203
• Device Sequence Number: 1
• Product Code: CAG
• 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
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: RT509-852
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2015
• 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