MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CONCHA NEPTUNE; HEATED HUMIDIFICATION SYSTEM

Catalog Number 425-00

Device Problem Overheating of Device (1437)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 01/07/2015

Event Type  malfunction  

Event Description

The customer alleges that the device overheats and then shuts off.The alleged issue was detected prior to use.No pt injury.

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 returned.The device history record investigation did not show issues related to complaint.A document assessment (fmea) was conducted and no changes were required.Corrective actions cannot be established since it is not necessary to receive the physical sample to perform a proper investigation and confirm the defect and determine a root cause.At this time since the device sample is not available, it is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed since the device sample is not available.If the device sample becomes available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend relating complaints.

• Brand Name: HUDSON CONCHA NEPTUNE
• Type of Device: HEATED HUMIDIFICATION SYSTEM
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate, b.c. 2147 8; MX 21478
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4451369
• MDR Text Key: 5429087
• Report Number: 3003898360-2015-00038
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2015

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: 425-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 01/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1