MAUDE Adverse Event Report: TELEFELX MEDICAL HUDSON AUQAPAK 340 SW, 240 ML W/040 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  

Event Description

The customer alleges that the aquapak was connected to two different wall flow-meters, and it did not "bubble" and let oxygen flow.The unit does not screw onto the oxygen connector to make flow through water.No patient injury reported.

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not received yet at our facility.Customer complaint cannot be confirmed, based only on the information provided, to perform a correct investigation and determine the source of the defect reported it is necessary to evaluate the sample involved in this complaint.An attempt to duplicate the failure mode was made, but at the time there is no inventory of the involved product code available at the facility and it is not being manufactured at the time; however, regarding other customer complaints from this same issue, a capa fail #(b)(4) was opened.If device sample becomes available at a later date, this complaint will be re-opened.

• Brand Name: HUDSON AUQAPAK 340 SW, 240 ML W/040 ADAPTOR
• Type of Device: HUMIDIFIER
• Manufacturer (Section D): TELEFELX MEDICAL; rtp 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: 4535710
• MDR Text Key: 22028296
• Report Number: 1417411-2015-00026
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• 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: Other
• Device Catalogue Number: 003-40
• Device Lot Number: H880003010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2015
• Initial Date FDA Received: 02/20/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1