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

Catalog Number 425-00

Device Problem Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2016

Event Type  malfunction  

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 required.Corrective 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 due to the lack of device sample 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 on similar complaints.

Event Description

The customer alleges that the unit shuts off intermittently.No patient injury reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and there were no defects observed.Functional testing was performed and the unit was connected to 110vac.The unit failed the initial power connect test.This failure is indicative of a defective power supply pcb.The on-board power supply pcb was by-passed with a known good power supply pcb and the test was attempted again, this time successfully.Based on the investigation performed, the reported complaint of "unit intermittently turns off" was confirmed.It was determined that the power supply pcb is defective.All units being returned for service will have power supply pcbs replaced.This unit was manufactured 22 nov 2010 and will be replaced.

Event Description

The customer alleges that the unit shuts off intermittently.No patient injury reported.

• 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 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5505140
• MDR Text Key: 40534786
• Report Number: 3003898360-2016-00288
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 425-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2011
• 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