MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON COMFORT FLO HUMIDIFICATION SYSTEM; RESPIRATORY GAS HUMIDIFIER

Catalog Number 2410

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.A device history review record could not be conducted since the lot number was not provided.No corrective action can be established at this moment since the device sample is not available for evaluation.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of the reported alleged defect it is necessary to evaluate the sample involved in this complaint.However as an additional test, samples of current production p/n 2410 were reviewed and functionally inspected for any issues that could be related to the customer complaint.If the device sample becomes available at a later date this complaint will be updated.

Event Description

The customer alleges that the wires overheated/burned and melted the circuit while in use.No patient injury or harm reported.

• Brand Name: HUDSON COMFORT FLO HUMIDIFICATION SYSTEM
• Type of Device: RESPIRATORY GAS HUMIDIFIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5829890
• MDR Text Key: 50654590
• Report Number: 3004365956-2016-00285
• 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: company representative,health
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2410
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2016
• 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