MAUDE Adverse Event Report: TELEFELX MEDICAL HUDSON HUMIDIFIER ADAPTOR 040

Catalog Number 000-40

Device Problem Restricted Flow rate (1248)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 11/18/2014

Event Type  malfunction  

Event Description

The customer alleges that there was restricted airflow of less than 10lpm and whistles when particular flow was exceeded.

Manufacturer Narrative

(b)(4).The user facility stated and acknowledged that the product was being used off label to achieve a high flow.A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.A review of manufacturing event log: shows no issues that may have contributed to any quality issues reported.All process parameters were within specification.All in-process qa inspections were acceptable.All post sterility and package integrity tests were acceptable.The complaint cannot be confirmed.Root cause is unknown.Teleflex will continue to monitor feedback from customers on issues related to restricted flow of less than 10 lpm.

• Brand Name: HUDSON HUMIDIFIER ADAPTOR 040
• Type of Device: HUMIDIFIER ADAPTOR
• Manufacturer (Section D): TELEFELX MEDICAL; research triangle park; NC
• Manufacturer (Section G): TELEFELX MEDICAL; 900 west university dr.; arlington heights IL 60004
• Manufacturer Contact: margie burton ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4570368
• MDR Text Key: 5476993
• Report Number: 1417411-2015-00027
• Device Sequence Number: 1
• Product Code: CAF
• 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: Other
• Type of Report: Initial
• Report Date: 02/04/2015

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: Other
• Device Catalogue Number: 000-40
• Device Lot Number: CE10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/04/2015
• Initial Date FDA Received: 03/03/2015
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1