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

Catalog Number 425-00

Device Problem Power Problem (3010)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/16/2015

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 10/05/2007.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 intermittently turns on and off.Unknown when alleged defect was detected.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was also performed and the unit was connected to 110 vac.The unit failed the initial power connect test with no electrical response at all.The unit was opened to perform a power supply pcb by-pass test, however upon disconnecting the power supply wiring harness, the connector crumbled.The brittle condition is the result of heat over a long period of time.Testing could not continue.Based on the investigation performed, the reported complaint was confirmed.The investigation revealed a defective electronic component.The root cause for the failure is unknown.A conclusion code could not be found as the complaint was confirmed; however, a root cause could not be determined.

Event Description

The event is reported as: the unit intermittently turns on and off.Unknown when alleged defect was detected.

• 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: 5329010
• MDR Text Key: 34437442
• Report Number: 3003898360-2015-00926
• 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: 12/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2015
• 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: 01/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2007
• 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