MAUDE Adverse Event Report: TELEFELX MEDICAL HUDSON CONCHAPAK MINI 440 ML W/LOW COMP COL; CONCHA COLUMN

Catalog Number 381-53

Device Problems Filling Problem (1233); Obstruction of Flow (2423); Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/08/2014

Event Type  malfunction  

Event Description

The complaint information received via medwatch.The customer alleges that the fill tube on the humidifier was obstructed with a foreign body.The customer reports that the humidifier chamber was empty and unable to be filled.

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

• Brand Name: HUDSON CONCHAPAK MINI 440 ML W/LOW COMP COL
• Type of Device: CONCHA COLUMN
• Manufacturer (Section D): TELEFELX MEDICAL; research triangle park NC
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4652903
• MDR Text Key: 18632727
• Report Number: 1417411-2015-00039
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 381-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2015
• 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
• Patient Age: 68 YR
• Patient Weight: 114