MAUDE Adverse Event Report: TELEFELX MEDICAL HUDSON CONCHA PAK SW 1650 ML PED W/COL; COLUMN FOR HUMIDIFICATION

Catalog Number 385-30

Device Problems Leak/Splash (1354); Overheating of Device (1437); Material Distortion (2977)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2015

Event Type  malfunction  

Event Description

The customer alleges that the column appeared to overheat and the outlet became distorted causing a leak in the ventilator connection to the column.The heater, column and circuit were replaced.No report of a patient injury.

Manufacturer Narrative

(b)(4).A visual and function test could not be conducted since the device sample was not returned for evaluation.Based on the failure mode reported it is necessary to receive the sample to perform a proper investigation.The failure mode cannot be duplicated on site.A device history record review could not be conducted since a lot number was not provided.No corrective action can be implemented due to the lack of sample and lot number to perform a proper investigation and determine a root cause.The customer complaint cannot be confirmed due to lack of the device sample and lot number to perform a proper investigation and determine a root cause.

• Brand Name: HUDSON CONCHA PAK SW 1650 ML PED W/COL
• Type of Device: COLUMN FOR HUMIDIFICATION
• Manufacturer (Section D): TELEFELX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 900 west university dr; arlington heights IL 60004
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4535711
• MDR Text Key: 19402691
• Report Number: 1417411-2015-00020
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/29/2015

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: Health Professional
• Device Catalogue Number: 385-30
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2015
• Initial Date FDA Received: 02/20/2015
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEATER; CIRCUIT