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

Catalog Number 425-00

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Inadequate Osseointegration (2646)

Event Date 11/04/2015

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 device was not returned at the time of this report.The device history record (dhr) review did not show issues related to the complaint.The device was manufactured on 07/03/2007.A document assessment (fmea-08-037) was conducted and no changes were required.The reported complaint cannot be confirmed since the device sample is not available to perform a proper investigation, determine the root cause and assign corrective actions.If the device sample becomes available at a later date, this complaint will be updated accordingly.

Event Description

The event is reported as: the unit will not stay on prior to use.There was no patient involvement.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no issues were observed.Functional testing was also performed and the unit was connected to 110 vac.It failed the initial contact test when both delta warning lights flashed and then the unit shut down completely with no further response.The failure is indicative of a power supply pcb failure.The onboard power supply pcb was by-passed with a known good power supply pcb.On the second attempt the unit passed the initial power connect test and the power-on self-test (p.O.S.T.) with no issues.During the temperature display accuracy test the unit displayed the correct temperatures and properly alarmed in the high temperature scenario.Based on the investigation performed, the reported complaint 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 04 jan 2007 and will be replaced.

Event Description

The event is reported as: the unit will not stay on prior to use.There was no patient involvement.

• 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: 5216617
• MDR Text Key: 31199328
• Report Number: 3003898360-2015-00822
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/05/2015

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 Catalogue Number: 425-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/05/2015
• Initial Date FDA Received: 11/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1