MAUDE Adverse Event Report: TELEFLEX HUDSON COMFORT FLO HUMIDIFICATION SYSTEM

Catalog Number 2410

Device Problems Overheating of Device (1437); Temperature Problem (3022)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 09/21/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the comfort-flo circuit became hot and caused a pt burn.The user facility reports that the circuit was lying across the pt's arm.The customer indicates that the pt was treated for the burn, the burn/wound is healing, and the pt is recovering.The pt was reported as having "low sensory" prior to this incident.

Manufacturer Narrative

Nine (9) pictures of catalog number 2410 (comfort flo humidification system) were received for analysis.They were visually inspected and the fault reported by the customer cannot be detected in the provided pictures.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.A dhr (device history record) review could not be conducted since the lot number was not provided.No corrective action can be established since the sample is not available to perform an investigation and determine the source of defect reported.This customer complaint can not be confirmed based on the review of the pictures since it is hard to appreciated the reported defect.In order to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.An attempt to duplicate the failure mode was made, but at the time there is no inventory of the involved product code available at the facility nor is being manufactured at the time.If device sample becomes available at a later date this complaint will be re-opened.

• Brand Name: HUDSON COMFORT FLO HUMIDIFICATION SYSTEM
• Type of Device: HUMIDIFICATION SYSTEM
• Manufacturer (Section D): TELEFLEX; rtp NC 27709
• Manufacturer Contact: margie burton, rn ,regulatory af ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 4168546
• MDR Text Key: 20453171
• Report Number: 3004365956-2014-00359
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2014

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: Health Professional
• Device Catalogue Number: 2410
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2014
• Initial Date FDA Received: 10/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONCHA NEPTUNE
• Patient Outcome(s): Other