MAUDE Adverse Event Report: TELEFLEX HUDSON CIRCUIT ACCESSORY, HEATED WIRE; BREATHING CIRCUIT

Catalog Number 780-20

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2014

Event Type  malfunction  

Event Description

The event reported as: the customer alleges that the circuit had a melted spot on the tubing.The heater and the circuit was removed and a complete new heater and circuit was set-up for the pt.The pt condition is reported as fine.

Manufacturer Narrative

The device sample was received by the mfr, but the investigation is incomplete at the time of this report.

• Brand Name: HUDSON CIRCUIT ACCESSORY, HEATED WIRE
• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): TELEFLEX; nuevo laredo, tamaulipas ; MX
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3909859
• MDR Text Key: 4585937
• Report Number: 3004365956-2014-00099
• 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: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 780-20
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/18/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEATER
• Patient Outcome(s): Required Intervention