MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON HUMID-FLO HME; CONDENSER, HEAT AND MOISTURE

Catalog Number 19912

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 11/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The original initial report, submitted on 11/28/2016, was submitted on time and accepted through the emdr system.This report is re-submitted due to an fda request to submit the initial report with the corrected mdr number.The correct mdr number for this report is 8040412-2017-00051.

Event Description

The customer alleges that the device did not pass the leak test on the evita ventilator.The leaking occurred where the two halves are joined.The alleged issue was detected during pre-testing.

• Brand Name: HUDSON HUMID-FLO HME
• Type of Device: CONDENSER, HEAT AND MOISTURE
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6377151
• MDR Text Key: 214771643
• Report Number: 8040412-2017-00051
• Device Sequence Number: 1
• Product Code: BYD
• 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: 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 19912
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2016
• 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