MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CONCHA NEPTUNE

Catalog Number 425-00

Device Problems Power Problem (3010); Noise, Audible (3273)

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

Event Date 04/09/2015

Event Type  malfunction  

Event Description

The customer alleges that the unit would not turn on and is making a clicking noise.

Manufacturer Narrative

Qn#(b)(4).Product usage when the alleged event was encountered is unknown.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.The device was manufactured on 08/26/2010.A document assessment (fema) was conducted and no changes were required.Correction actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time since the sample is not available, it is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed since the sample is not available to perform a proper investigation and determine the root cause.If the device sample becomes available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend of similar complaints.

• Brand Name: HUDSON CONCHA NEPTUNE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; prolongacion mision eusebio; kino # 1316,rancho el descanso; tecate, b.c. 2147 8 MX; MX 21478 MX
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd.; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4749242
• MDR Text Key: 5771853
• Report Number: 3003898360-2015-00306
• 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: 04/09/2015

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: 04/09/2015
• Initial Date FDA Received: 05/04/2015
• 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