MAUDE Adverse Event Report: TELEFELX MEDICAL HUDSON AQUAPAK 340 SW, 340 ML W/340 ADAPTOR; HUMIDIFIER

Catalog Number 003-40

Device Problems Restricted Flow rate (1248); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual inspection of the product involved in the complaint could not be conducted since the product was not received at our facility and no pictures received for eval.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.Records reviewed showed that there were no issues related to functional issues on the molded component involved in this complaint (b)(4) (snap-on flowmeter adaptor) batch #1-2314741, 5-2214741, 5-2214742, 6-2214741, 6-2214742, 7-2214741 and 7-2214742 during the manufacture of the material.The dhr (device history record) of product code 003-40 with batch number 468147 shows that the assembly is manufactured with component mp-0321.No corrective action can be established at this moment since the device sample or pictures of it are not available for eval.Customer complaint cannot be confirmed based only on the info provided, to perform a proper investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.An attempt to duplicate the failure mode was made but at time there is no inventory of the involved product code available at the facility and it is not being manufactured at the time.If device sample becomes available at a later date, this complaint will be re-opened.

Event Description

The customer alleges the device does not screw onto the oxygen supply connector to make flow through water.No pt injury reported.

• Brand Name: HUDSON AQUAPAK 340 SW, 340 ML W/340 ADAPTOR
• Type of Device: HUMIDIFIER
• 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, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4490966
• MDR Text Key: 48149243
• Report Number: 1417411-2015-00014
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2015

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: No Information
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: 003-40
• Device Lot Number: 468147
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2015
• Initial Date FDA Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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